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Note: Walk In Interview at Indore Date & Time: 27th July, 2025 Sunday at 09:00 AM Onwards Designation: QC Officer-Sr. Officer Job Location: Daman & Sikkim Qualification: M.Sc. / B. Pharm/ M. Pharm Experience: 02 to 07 Years (OSD/DPI/Liquid/Injection) Required Candidate profile Responsibilities: -Experience in Finished Goods, Raw Material, Stability & GLP. -Experience in in Raw Material, Finished Goods, GLP, Stability, Micro, Packing Material, Stability and Validation.

As an Executive / Senior Executive in Quality Control (QC), you will play a crucial role in ensuring that products consistently meet the defined quality standards of the company. Your responsibilities will include conducting quality testing of raw materials, in-process, and finished products as per Standard Operating Procedures (SOPs). It will be your duty to identify, document, and escalate any non-conformities or deviations found during testing, while maintaining thorough and accurate records of test results, logs, and batch documents. Your role will also involve ensuring alignment with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other relevant regulatory requirements. Collaboration with the production team to troubleshoot and resolve quality-related concerns will be essential. Moreover, you will be preparing and assisting in internal and external audits as well as regulatory inspections. Monitoring key quality metrics and providing inputs for process improvements are also part of your responsibilities. To excel in this role, you should have 2 to 5 years of experience in QC roles within the cosmetics, pharmaceutical, or FMCG industries. A strong technical understanding of quality control protocols, lab equipment, and analytical techniques is necessary. Knowledge of regulatory frameworks such as ISO, WHO-GMP, and FDA will be beneficial. Your detail-oriented mindset, coupled with strong documentation and analytical skills, will be key to success. Proficiency in handling quality management systems (QMS) and MS Office is essential. Effective communication and interpersonal abilities will also be valuable in this position.,

This role involves working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps , use cases , and test plans for the software development teams. This enabl es the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Y ou will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre- clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem , and provide technical support, training, and infrastructure management , and ensure it meets the needs of our Amgen R esearch community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework ( SAFe ) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and milestones Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. Basic Qualifications and Experience: Master s degree with 1 - 3 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Bachelor s degree with 3 - 5 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/Bioinformatics or related field , OR Diploma with 7 - 9 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry /Cheminformatics , Computational Biology/ Bioinformatics or related field , OR Preferred Qualifications: 3 + years of experience in implementing and supporting LIMS platforms . Functional Skills: Must-Have Skills : Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data E xperience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS platforms such as STARLIMS, Watson LIMS , LabVantage, etc. Good-to-Have Skills: Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation , and k nowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud ( e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile process es and principles for coordinated solutions and teams via SAFe Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certification s: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills EQUAL OPPORTUNITY STATEMENT We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation . .

Let s do this. Let s change the world. In this vital role you will lead the execution of complex or novel assignments requiring strategic planning and development of new and/or improved validation techniques, deviations, and procedures. In this position you will supervise validation activities through internal audits and conduct risk assessments to identify the need for requalification and establish policies for computer system re-validation. This individual will actively participate during all phases of qualification/validation of computerized systems: evaluate projects; provide guidance and technical information to others (lead qualification/validation activities); determine and establish requirements for qualification/validation of each individual system/equipment; formulate independent decisions related to qualification/verification activities. Responsibilities Review validation/qualification packages of computerized systems for completeness and accuracy, sound rationale, Regulatory expectations, compliance with validation policies and procedures, and accurate data analysis. Serve as Owner or QA Contact for handling the Deviations. Compare results against acceptance criteria and work with appropriate departments to resolve exceptions and deviations. Bring critical exceptions or deviations to management s attention and initiate and enforce necessary improvements and corrections to established systems and processes. Initiate, implement, and track completion of Change Control and deviation requests related to computer systems. Participation and support of regulatory inspections. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN). The candidate will be required to go into the office as dictated by the site policy. Validation Validation Documentation: Review and approve all validation documentation, ensuring compliance with regulatory requirements and internal quality standards. Requirement Specifications & Test Protocols: Review and approve Requirement Specifications, Design Specifications, Test Protocols, Validation Plans, Summary Reports, and Requirement Traceability Matrices. System Life Cycle Documents: Review and approve System Life Cycle Documents (e.g., test protocols) prior to their use in production. Data Integrity Assessments: Review and approve Data Integrity Assessments to ensure data is accurate and complies with regulatory standards. Change Control Management: Initiate, review, and approve Change Control requests, acting as the QA contact for changes in systems (e.g Trackwise/Veeva , ServiceNow) Periodic Review/Audit Trail System Periodic Reviews & Audit Trails: Review and approve periodic system reviews and audit trail reports to ensure system integrity and compliance. Supplier Management Supplier Evaluations : Provide support for supplier evaluations as needed, ensuring suppliers meet quality, compliance, and performance standards. Deviation & CAPA Management: Initiate and manage deviations (major and minor) as required. Serve as the primary QA contact for deviations, ensuring proper investigation and resolution. Act as the quality reviewer and approve for problem records in ServiceNow, ensuring that all records meet internal quality standards. CAPA & Effectiveness Verification (EV): Serve as the QA contact or owner for Corrective and Preventive Actions (CAPA) and Effectiveness Verification (EV) records, ensuring timely and effective resolution. Responsible as a Business Owner for overseeing and managing specific GxP Computerized Systems programs and projects, ensuring compliance with regulatory standards and alignment with business objectives. Independently develop solutions that are thorough, practical and consistent with functional objectives. Review and approve operational and administrative Standard Operating Procedures (SOPs) and Work Instructions, ensuring alignment with regulatory and quality standards. Apply analytical skills to evaluate complex problems, utilizing both qualitative and quantitative data, including trend analysis, to develop effective solutions. Contributes to continuous improvement efforts and initiatives. Assists with training initiatives and strategy as required. Provides support for the Management Review Process when needed. Supports the Integrated Systems Assessment (ISA) Process as necessary. Participates in and aids with regulatory inspections as required. What we expect from you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree with a minimum of 7 years experience in Software and Systems Quality assurance OR Bachelor s degree with a minimum of 10 years of Software and Systems Quality assurance experience Preferred Qualifications: Strong understanding of the regulations outlined in 21 CFR Part 11, EU Annex 11, GAMP standards. Proven experience in the validation of computerized systems and strong understanding and application of GxP regulations (GMP, GLP, GCP, GPvP, GDP). Experience managing quality assurance processes, including Change controls, Deviations, CAPAs and effectiveness checks. Demonstrated ability to handle and resolve complex quality issues using analytical and problem-solving skills. Strong decision-making abilities with the capacity to drive tasks to completion. Ability to work independently with minimal supervision. Leadership skills with experience leading projects, teams, or tasks. Experience with tools and systems such as HP ALM, Jira, Confluence, Track Wise , Documentation Management Systems, LIMS, SAP and Maximo. Broad technical expertise within specialty area and familiarity with industry standards. Ability to provide training, guidance, and contribute to team quality. Works closely with leadership / senior staff and external experts to extend capabilities and enhance performance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will responsible for leading and charting the course for the Research Informatics Biological Studies team that enables technology and data capabilities for Amgen Research to evaluate drug candidates and assess their abilities to affect the biology of drug targets. The role will provide leadership to the team that implements software platforms that enable the capture, analysis, storage, and report of in vitro assays and in vivo / pre-clinical studies, as well as those that manage compound inventories / biological sample banks. This individual will be responsible for developing and leading a highly talented team that is built for delivering high-end and innovative technologies. As a scientific domain expert, this role will collaborate with cross-functional teams to identify strategies for implementation and adoption of standardized experimental data management platforms for drug discovery research. The ideal candidate will have a strong background in biopharma scientific domains as well as informatics solution delivery with a proven track record of leadership in technology-driven environments that facilitate R&D activities and has a passion for fostering innovation and excellence in the biotechnology industry. The candidate will have experience in evaluation and coaching of Technology Analysts and Managers, coupled with leadership and transformation experience. Additionally, collaboration with global teams is required to ensure seamless integration and operational excellence. This role demands the ability to drive and deliver against key organizational critical initiatives, foster a collaborative environment, and deliver high-quality results in a matrixed organizational structure. Roles & Responsibilities: Lead and manage diverse teams within a matrixed organization. Collaborate with geographically dispersed teams, including those in the US, EU, and other international locations. Provide technology delivery leadership and domain expertise for Biological Studies product teams that enable in silico, in vitro and in vivo experimentation. Partner with Research and Technology leaders to create technology delivery strategy and prioritized agenda for Biological Studies. Provide leadership for the implementation and support of specialized technology platforms that enable streamlined and automated scientific data management ensuring data integrity from lab to analytics. Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities. Follow global standards and practices. Foster a culture of collaboration, innovation, and continuous improvement. Develop talent, motivate the team, delegate effectively, champion diversity within the team and act as a role model of servant leadership. Manage, grow, and develop the Amgen Technology team in India, ensuring global ways of working are embedded in the local organization. Understand the decision-making process, workflows, and business and information needs of business partners and collaborators. Work with Product Owners, Service Owners and/or delivery teams to ensure that delivery matches commitments, acting as a partner concern point and facilitating communication when service commitments are not met. Ensure communication of key performance metrics and analysis of unmet needs. Ensure ongoing alignment with strategy, compliance, and regulatory requirements for technology investments and services. Facilitate standard methodology sharing, ensuring ongoing alignment with the Technology & Digital strategy. Oversee operating budgets and product team budgets, ensuring regular review of actuals and latest estimates, managing according to agreed governance. Ensure alignment of Technology service plans across organization. Provide education to new partners with regards to Technology service offerings. Remain accountable for ensuring overall organizational compliance to quality/compliance requirements such as GXP and Privacy. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 8 to 10 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR OR Bachelor s degree and 10 to 14 years of [Job Code s DisciLife Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Diploma and 14 to 18 years of Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field, OR Demonstrated expertise in a scientific domain area and related technology needs Experience performing or enabling data capture and analysis from instruments in a research laboratory or vivarium Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Demonstrated experience building strong teams with consistent practices in a matrix organization Preferred Qualifications: 6+ years of experience in implementing and supporting biopharma scientific software platforms. Experience in a leadership role within a pharmaceutical or technology organization Demonstrated expertise enabling technology for drug discovery research capabilities such as high throughput screening, high content imaging, in vitro assay technologies, compound inventory management, in vivo studies, digital pathology, PK/PD assessments, GLP tox studies, etc. Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), and Laboratory Information Management Systems (LIMS). Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP). Experience in AI and machine learning for drug discovery research and preclinical development. Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Strong analytical/critical-thinking and decision-making abilities Ability to work effectively in a fast-paced, dynamic environment Experience in establishing business partnerships and IS governance practices involving senior business collaborators Professional Certifications SAFe Agilist, Certified Agile Leader or similar (preferred) Soft Skills: Excellent leadership and team management skills Strong transformation and change management experience Exceptional collaboration and communication skills High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented with a focus on achieving team goals Strong presentation and public speaking skills Ability to work effectively with global, virtual teams What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. l The Quality Compliance Manager is a global role and part of the Continuous Improvement & Innovation team for the R&D Quality Organization. This role will support processes and efforts related to continuous improvement and change management. They will be a vital part of Amgens Quality Management System, providing expert support to create and manage R&D controlled processes aimed at continuous improvement through the application of standard methodologies (Lean, DMAIC, Six Sigma). The Quality Compliance Manager will contribute to implementing strategies and providing leadership to ensure excellence in R&D Quality Processes. As an integral team member working globally with Business Process Owners to ensure compliance with regulations and other requirements. This individual will be part of supporting the digital quality management system (DQMS) as an SME to support new and the core processes managed in Quality. Roles & Responsibilities: This role will work both independently and in a team environment to foster collaborative relationships with R&D and OCMO to assess the current state of quality, identify potential quality risks, and explore innovative strategies for enhancing the Quality Management System (QMS) in a fast-paced R&D setting. they will also be responsible for any innovative, process excellence strategy activities. Design, implement, and/or support proactive, comprehensive, risk-based quality improvement strategies for R&D, OCMO, and R&D Quality through established processes and methodologies (Lean, DMAIC, Six Sigma, Kaizen, Quality by Design, etc.). Supervise improvement initiatives for R&D Quality informed by insights from Amgens quality system, including audits/inspection findings, deviations, and quality trend analyses. Serves as a cornerstone of quality and innovative approaches to enhance the QMS within an agile R&D environment. Lead Organizational Change Management (OCM) initiatives for projects spearheaded by R&D Quality. Provide input and technical expertise to establish, implement, maintain, and adapt continuous improvement methodologies, for example Six Sigma, Lean, Kaizen and ADKAR. Assist OCM strategies for initiatives driven by Operations and R&D/OCMO that may affect the R&D Quality Organization. Provide quality expertise and guidance to R&D functions and business process owners to ensure comprehensive, clear, and well-managed organizational changes Partner with process owners, training leadership, and business process management to implement robust communication strategies and training Manage, organize and analyze data through different systems, tools, or platforms, including Excel and Smartsheet What we expect of you Basic Qualifications and Experience: Master s degree with 4-6 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Bachelor s degree and 6-8 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred. Functional Skills: Must-Have Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Good-to-Have Skills: Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP. Experience working in a multinational environment with global teams. Soft Skills: Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure Equal opportunity statement What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Let s do this. Let s change the world. In this vital role you will work closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality work from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Roles & Responsibilities: Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Manage a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and achievements Identify and manage risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Foster a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Master s degree and 4 to 6 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Bachelor s degree and 6 to 8 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field OR Diploma and 10 to 12 years of experience in Computer Science, IT, Computational Chemistry, Computational Biology/Bioinformatics or related field Must-Have Skills: Demonstrated expertise in a scientific domain area and related technology needs Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS/ELN platforms such as Benchling, Revvity, IDBS, STARLIMS, Watson, LabVantage, etc. Experience using platforms such as Spotfire, Tableau, Power BI, etc., to build dashboards and reports Preferred Qualifications: 5+ years of experience in designing and supporting biopharma scientific software platforms Experience leading the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Experience in establishing business partnerships and IS governance practices involving senior business collaborators Knowledge of business analysis standard methodologies, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

The Quality Compliance Senior Manager is a global role and part of the Clinical & Research Quality (CRQ) team for the R&D Quality Organization. CRQ organization plays a critical role in ensuring that our research and development activities are conducted in an ethical and responsible manner . CRQ is responsible for ensuring that our research and development activities meet the highest standards of quality and compliance, ultimately keeping patients safe, protecting their welfare, while ensuring that all data produced has integrity. In this vital role , the Quality Compliance Senior Manager will contribute to providing leadership to ensure excellence in R&D Quality Processes is maintained through oversight and improvements when compliance issues are identified In addition, this role will serve as a mentor for Amgen staff in India who will be working to advance the Quality System, and they will act to manage day to day activities for the team. They will be an integral team member working globally with Business Process Owners to ensure compliance with regulations and other business requirements. This role will be part of supporting the digital quality management system (DQMS) as a Subject Matter Expert ( SME ) to support the core processes managed in Quality. Additionally, the Quality Compliance Senior Manager will provide proactive end to end quality support for the management of Quality Incidents/Quality Events , working closely with Quality Leads in approving investigations , including root cause analysis (RCA) and C orrective & Preventive Action (C APA ) plans. Roles & Responsibilities: The Quality Compliance Senior Manager will work both independently and in a team environment to foster collaborative relationships with in R&D Quality. In this vital role , they will be responsible for supporting processes and operational activities related to ; overseeing deviations, preparation of audits and inspections across R&D Quality including Good Pharmacovigilance Practice ( GPvP ), Good Clinical Practice (GCP) and Good Laboratory Practice (GLP). As part of strengthening and advancing Amgen s R&D QMS, this role provides end-to-end quality support to Deviation owners, RCA owners, and CAPA owners. Manages the Amgen India R&D Quality team to ensure that the team is supported and managed on a day-to-day basis. Support s the intake, triage, and categorization of deviations, ensuring appropriate classification and documentation. Facilitate s timely and thorough deviation investigations in collaboration with functional area r epresentatives and Quality Leads. E nsure s consistent and compliant documentation of deviation records within the electronic quality management system ( D QMS). Monitor s and ensure s adherence to timelines, escalating delays and risks as needed. Support s Global Patient Safety and Global Development teams in GxP inspection management activities and GxP audits from business partners Identif ies , lead s , or contribute s to continuous improvement initiatives to enhance CAPA management practices. Collaborate s with cross-functional partners to ensure processes remain effective, efficient, and aligned with industry best practices and evolving regulations. Ensure s the integrity, traceability, and quality of deviation and CAPA records in compliance with ALCOA+ principles. Monitor s quality metrics and key performance indicators (KPIs) related to deviation and CAPA management. Analyses trends and perform root cause trending to identify systemic issues and opportunities for process improvement. Manage s , organize s and analyse s data through different systems, tools, or platforms, including Excel and Smartsheet Maintain s knowledge of current regulatory and quality practices/issues Maintain s the Global R&D CRQ and SMQ SharePoint sites Manage s the appropriate archival and retention of audit documentation. Basic Quali fi cations and Experience: Master s degree with 10-12 years of Pharma and Biotech R&D or commercial manufacturing Quality experience. Continuous Improvement/Change Management experience is preferred Additional Competencies/Skills: Exceptional attention to detail and accuracy in all deliverables. Ability to work independently and proactively in a fast-paced environment. Proficiency in Smartsheet, Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx ) Good team building skills and the ability to on-board new employees and develop them over time Familiarity with project management tools and methodologies. Knowledge of GCP, GLP and/or GPvP . Experience working in a multinational environment with global teams. Excellent verbal and written communication skills. High degree of professionalism and interpersonal skills. Strong problem-solving abilities and adaptability to changing priorities. Collaborative attitude and ability to build positive relationships across diverse teams. Resilience, discretion, and the ability to thrive under pressure

Let s do this. Let s change the world. In this vital role you will be working closely with Amgen Research partners and Technology peers to ensure that the technology/ data needs for drug discovery research are translated into technical requirements for solution implementation. The role leverages scientific domain and business process expertise to detail product requirements as epics and user stories, along with supporting artifacts like business process maps, use cases, and test plans for the software development teams. This enables the delivery team to estimate, plan, and commit to delivery with high confidence and identify test cases and scenarios to ensure the quality and performance of IT Systems. Function as a Scientific Business Systems Analyst within a Scaled Agile Framework (SAFe) product team Serve as a liaison between global Research Informatics functional areas and global research scientists, prioritizing their needs and expectations Handle a suite of custom internal platforms, commercial off-the-shelf (COTS) software, and systems integrations Lead the technology ecosystem for in vivo study data management and ensure that the platform meets their requirements for data analysis and data integrity Translate complex scientific and technological needs into clear, actionable requirements for development teams Develop and maintain a product roadmap that clearly outlines the planned features and enhancements, timelines, and breakthroughs Identify and handle risks associated with the systems, including technological risks, scientific validation, and user acceptance Develop documentations, communication plans and training plans for end users Ensure scientific data operations are scoped into building Research-wide Artificial Intelligence/Machine Learning capabilities Ensure operational excellence, cybersecurity and compliance. Collaborate with geographically dispersed teams, including those in the US and other international locations. Develop a culture of collaboration, innovation, and continuous improvement. What we expect of you We are all different, yet we all use our unique contributions to serve patients. You will join a multi-functional team of scientists and software professionals that enables technology and data capabilities to evaluate drug candidates and assess their abilities to affect the biology of drug targets. This team implements LIMS platforms that enable the capture, analysis, storage, and report of pre-clinical and clinical studies as well as those that manage biological sample banks. You will collaborate with Product Owners and developers to maintain an efficient and consistent process, ensuring quality deliverables from the team. You will implement and manage scientific software platforms across the research informatics ecosystem, and provide technical support, training, and infrastructure management, and ensure it meets the needs of our Amgen Research community. Basic Qualifications: Bachelor s degree and 2 to 6 years of experience in Life Sciences, Computer Science, IT, Computational Chemistry/Cheminformatics, Computational Biology/Bioinformatics or related field Demonstrated expertise in a scientific domain area and related technology needs Excellent problem-solving skills and a passion for tackling complex challenges in drug discovery with technology and data Experience with writing user requirements and acceptance criteria in agile project management systems such as JIRA Experience in configuration and administration of LIMS platforms such as STARLIMS, Watson LIMS, LabVantage, etc. Preferred Qualifications: 1+ years of experience in implementing and supporting LIMS platforms Experience in the implementation of scientific software platforms, Electronic Lab Notebook (ELN), or Laboratory Information Management Systems (LIMS) Experience handling GxP data and system validation, and knowledge of regulatory requirements affecting laboratory data (e.g., FDA 21 CFR Part 11, GLP, GCP) Knowledge of bioanalytical workflows and/or biospecimen management Experience in AI and machine learning for drug discovery research and preclinical development Experience with cloud (e.g. AWS) and on-premise infrastructure In-depth knowledge of Agile processes and principles for coordinated solutions and teams via SAFe Knowledge of business analysis best practices, DevOps, Continuous Integration, and Continuous Delivery methodology Professional Certifications: SAFe for Teams certification (preferred) Soft Skills: Able to work under minimal supervision Excellent analytical and gap/fit assessment skills Strong verbal and written communication skills Ability to work effectively with global, virtual teams High degree of initiative and self-motivation Ability to manage multiple priorities successfully Team-oriented, with a focus on achieving team goals Strong presentation and public speaking skills What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.

Should be capable of handling wet analysis like LOD, Ash content, Moisture content analysis etc Should have the knowledge of instrumentation analysis like HPLC , GC , IR , UV , Titrator etc,, Should have knowledge of GLP , GDP and GMP

Role & responsibilities Required for Quality Control(Formulations) Quality Control(QC)- Need 1 to 5 years of experience. *Analysis of Finished Product & Stability *GLP and LIMS, Documentation Preferred candidate profile Perks and benefits

Job Summary: We are looking for an experienced professional to manage and validate GxP computerized systems in a regulated pharmaceutical environment. The ideal candidate will play a key role in ensuring IT compliance with industry regulations and supporting core Quality Management System activities. Key Responsibilities: Installation and configuration of operating systems and other applications Diagnosing and troubleshooting of computer system and software problems Maintain an inventory of GxP computerized systems. Preparation and implementation of all the IT procedures as per GMP requirements. Responsible for Electronic data backup, archival and restoration. Verification of daily backup for electronic data generated for instruments. User management (Creation / modification of User IDs and passwords, assigning privileges) for laboratory and GMP Softwares. Developing the validation deliverables for computerized systems used in GLP, GMP and GCP environments. (Manufacturing and Laboratory Systems) Preparation, execution and reporting of GxP computerized systems validation deliverables Maintain the validated state of all GxP computerized systems Conduct periodic reviews of all GxP computerized systems to ensure continued compliance. Manage QMS activities to ensure timely completion of action items, including Change Controls, Deviations, investigations, and CAPAs. Review protocols, QMS documents, CSV deliverables, and other related documents to ensure accuracy and compliance. Good knowledge of GMP, 21 CFR Part 11, Annex 11, GAMP 5, Data Integrity requirements for Pharma Required Skills & Experience: 3-4 years in Pharma industry Strong working knowledge of GMP, 21 CFR Part 11, Annex 11, and GAMP 5 Hands-on experience in validation of GxP systems within a pharma or life sciences setup Solid understanding of pharmaceutical regulatory and compliance frameworks Educational Qualification: M.Sc / B.E / B.Tech / MCA (with relevant industry experience)

About Apotex Inc. Apotex Inc. is a Canadian-based global health company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 6000 people worldwide in manufacturing, R&D, and commercial operations. Apotex medicines are accessible to patients in more than 70 countries globally. Through vertical integration, the Apotex group is focused on the development and sale of generic, biosimilar and specialty products. For more information visit: www.apotex.com . Job Summary To ensure planning and monitoring of analytical activities, Instrument Calibration / Qualification, Investigations and Documentation as per the procedure in Quality control at Apotex Research Pvt. Ltd. Job Responsibilities Report to Head of Quality & Compliance regarding day to day activities to Head, Quality Control. Ensure the operations in Quality Control Laboratory as per the established standard procedure. Identify the departmental employees training needs and to fulfil the same. Provide support to Manufacturing Operations during the execution of exhibit batches / commercial batches within the stipulated time line. Assess, review, approval and ensure the timely completion of the changes in QC department as per established & approved change control procedure. Ensure timely completion of analysis of commercial samples. Ensure smooth functioning of all laboratory instruments in co-ordination with service engineers. Responsible for reviewing and approval SOP s and directions for testing of laboratory samples in QC. Perform all work in accordance with all established regulatory and compliance and safety requirements. Conduct investigation for OOS / OOT results, and to identify assignable cause wherever applicable and to ensure timely completion of laboratory analytical investigations. Evaluation of Investigation, Deviations, CAPA and Change Control Records and approval as Manager Approval . Ensure a disciplined work environment and to provide expertise to subordinate \ colleagues in proper performance of laboratory procedures. Interact with QA department / Auditor during inspections or any audit conducted by regulatory authorities. Assist Quality group in various activities like data compilation for APQR, Training, Vendor development programme, Self-inspection and External audit programme. Participate in handling of Market complaints / Product recalls / Quality related returns (if any) in co-ordination with Quality group at Apotex affiliates and responding the same if required. Ensure to update (self) with latest cGMP / GLP / Regulatory requirements and to train the same to the departmental people. Participate and lead performance conversations with employees, including monthly one on ones, to connect on performance; check in on employee s progress toward achieving Objectives, offer support and remove barriers; and, communicate and revisit performance expectations to reinforce and encourage high performance culture and a safe working environment for all employees. Utilize open, honest, two way communication to build trust-based relationships with employees, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development. Create a culture which values trust and provides the opportunity for Employee development and growth in pursuit of our purpose and demonstrating our core Values Collaboration, Courage, Perseverance and Passion. Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process. Ensure adherence of team members (direct reports) with all compliance programs and company policies and procedures. Take up any other work allotted by seniors and to fulfil the same. Job Requirements Education Minimum MSc /B Pharma or any equivalent degree. Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonnel skills. Proficient in MS office tools. Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports and analytical data etc. Knowledge on investigation and deviation report preparation. Having good command on trouble shooting on instrument and analysis. Having well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities. Able to priortise the task, best in effective planning of work activities to meet the timelines. Experience Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry. At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.

Designation: Sr. Executive Job Location: Bangalore Department: Engineering and Maintenance About Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation. Job Purpose To ensure the efficient operation, maintenance, and compliance of plant equipment and laboratory instruments by managing preventive maintenance programs, troubleshooting and repairing machinery, coordinating with vendors, and adhering to safety and quality standards. This role aims to minimize downtime, optimize equipment performance, and support sustainable and safe facility operations. Key Responsibilities: Follow established company procedures and policies to ensure compliance and operational efficiency. Adhere strictly to Standard Operating Procedures (SOPs), Safety protocols, Good Laboratory Practices (GLP), Quality Management Systems (QMS), and Environment, Health, Safety, and Security (EHSS) requirements. Prepare and maintain SOPs related to Equipment Asset Management (EAM). Develop and update the equipment master list and maintenance planners. Plan and review preventive maintenance activities as per schedule, coordinating closely with equipment users. Coordinate with vendors for preventive maintenance of Annual Maintenance Contract (AMC) equipment. Respond promptly to equipment and instrument breakdowns, ensuring timely resolution. Identify, procure, and maintain critical spare parts to minimize downtime. Implement equipment and facility modifications based on process requirements. Plan and oversee HVAC validation processes in coordination with vendors. Conduct energy conservation initiatives to optimize resource usage. Routine Maintenance Perform regular instrumentation maintenance activities on equipment to prevent malfunctions and downtime. Record Keeping Maintain detailed records of calibration reports, schedules, and maintenance activities to ensure traceability and compliance. Performance Testing Conduct performance tests on plant equipment using devices such as tachometers, pressure gauges, flowmeters, ammeters, and voltmeters. Troubleshooting & Repair Diagnose, troubleshoot, update, and repair malfunctioning plant equipment including air handling units (AHU), drive units. Safety Compliance Ensure strict adherence to safe work practices and procedures, including lockout/tagout protocols and confined space regulations. Operation of Equipment Operate various utility and laboratory equipment as necessary to support plant operations. Educational Qualification: BE in Electronics & Communications or BE Instrumentations Technical/Functional Skills: Equipment Asset Management (EAM): Proficient in preparing and maintaining SOPs, equipment master lists, and maintenance planners. Preventive Maintenance Planning: Skilled in scheduling, coordinating, and reviewing preventive maintenance activities in compliance with AMC agreements. Troubleshooting & Repair: Expertise in diagnosing, troubleshooting, and repairing instrumentation and plant equipment such as AHUs, drive units, and laboratory instruments. Calibration & Performance Testing: Experienced in conducting calibration and performance testing using tachometers, pressure gauges, flowmeters, ammeters, and voltmeters. Regulatory Compliance: Knowledgeable in GLP, SOP adherence, QMS, EHSS protocols, and safety regulations including lockout/tagout and confined space procedures. Vendor Coordination: Ability to liaise with vendors for equipment maintenance, AMC services, and HVAC validation processes. Energy Conservation: Implementing energy-saving initiatives to optimize resource usage and reduce operational costs. Record Keeping & Documentation: Maintaining detailed calibration reports, maintenance schedules, and compliance documentation. Facility & Equipment Modification: Capability to plan and implement modifications based on process requirements. Operation of Utility & Laboratory Equipment: Skilled in operating various plant and lab equipment to support operational needs. Experience: 5-7 years in the relevant regulated environment Behavioral Skills: Attention to Detail: Meticulous in performing calibrations, inspections, and maintenance to ensure accuracy and compliance with standards. Problem-Solving: Strong analytical skills to diagnose issues quickly and develop effective solutions for complex instrumentation problems. Communication: Clear and concise in reporting technical findings and collaborating with cross-functional teams including maintenance, operations, and safety. Time Management: Ability to prioritize tasks efficiently, manage multiple maintenance schedules, and meet deadlines without compromising quality. Adaptability: Flexible to work in changing environments and handle unexpected equipment breakdowns with calm and resourcefulness. Teamwork: Cooperative and supportive working style, able to work well with technicians, engineers, and operators. Safety-Conscious: Proactively adheres to safety protocols and promotes a culture of safe work practices within the team. Continuous Learning: Willingness to stay updated with the latest instrumentation technologies, calibration techniques, and industry best practices. Accountability: Takes ownership of tasks and responsibilities, ensuring reliability and consistency in maintenance and calibration work. Initiative: Proactively identifies areas for improvement and suggests innovative solutions to enhance process efficiency and equipment performance. Equal Opportunity Employer: .

Oversees QC activities, staff training, SOPs, calibrations, GLP compliance, audits, records, and lab investigations (OOS/OOT) and aligns QC goals with production and ensures lab standards (candidates having approval from Raj. FDA will be preferred).

Develop, implement & maintain a robust Quality Management System (QMS) in compliance with applicable regulations (GLP, GCP, GXP, ICH guidelines) Create, review, and manage SOPs, work instructions, protocols, reports & documentation across departments Required Candidate profile 4+ years of experience in QA/QC within the pharmaceutical, biotech or drug discovery industry. Quality control certifications are preferred In depth understanding of QA/QC procedures & legal standards

You will be responsible for performing chemical and instrumentation analysis on various materials including in-process, raw materials, packing materials, intermediates, and finished products. Your primary goal will be to ensure compliance with dispatch timelines as per the monthly schedule provided by PPL. Your duties will include conducting instrumentation analysis using ICP-MS and LC-MS for the mentioned materials to meet dispatch timelines. Additionally, you will be involved in analytical method developments, validations, transfers, and verifications using ICP-MS and LC-MS/MS. You will be required to prepare and review protocols, worksheets, and reports for method developments, validations, verifications, and transfers. Allotting work to chemists within the section, calibrating instruments, maintaining documentation online, and ensuring minimum stock levels for various materials and standards will also be part of your responsibilities. Monitoring and reviewing analytical data, calibration data, and qualification data, as well as ensuring instruments are calibrated and maintained in working condition, will be crucial tasks. You will also play a key role in reducing lab incidences, implementing CAPA, and maintaining safe working conditions. Collaboration with QA, Production, PPIC, Warehouse, and TSD for smooth dispatches, as well as training employees on GLP/GMP and coordinating with external laboratories, will be essential aspects of your role. Your commitment to data integrity, timely analysis and release of batches, cost control, and adherence to safety practices will contribute to the overall success of the team. This position requires a Bachelor's degree and offers an opportunity to work with Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) known for its end-to-end development and manufacturing solutions across the drug life cycle. PPAs serves customers globally and provides a wide range of services, making it a preferred partner for innovators and generic companies.,

As an Assistant Manager or Team Leader at Synnat Pharma in Visakhapatnam, you will play a crucial role in leading method development, validation, stability studies, and technology transfer activities. Your meticulous nature and extensive experience will be essential in collaborating closely with R&D, QC, and Regulatory teams to support product development and ensure compliance with global pharmaceutical standards. You should possess strong analytical expertise, leadership skills, and a dedication to regulatory compliance and continuous improvement. Your responsibilities will include developing, optimizing, and validating analytical methods such as HPLC, GC, UV-Vis, and Dissolution according to ICH and regulatory guidelines. You will be responsible for preparing and maintaining validation protocols, analytical reports, and ensuring compliance with Good Documentation Practices (GDP). Additionally, you will oversee method transfer to QC, provide training, and address any troubleshooting issues that may arise. Conducting stability studies, preparing data reports, and collaborating with cross-functional teams to support product development will also be part of your role. Furthermore, you will be expected to investigate and resolve analytical issues, including OOS, OOT, and deviations, and implement Corrective and Preventive Actions (CAPAs) as necessary. Maintaining up-to-date documentation and ensuring compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) will be integral to your responsibilities. You will also evaluate vendors and key starting materials (KSMs) and provide insights to management based on your findings. In terms of past experience, you should have a strong understanding of analytical chemistry principles and techniques, including HPLC, GC, Dissolution, and UV-Vis. Proven experience in method development, validation, and regulatory compliance is crucial for this role. Familiarity with global pharmaceutical regulations such as those from the FDA, EMA, WHO, and ICH guidelines is essential. You should also be skilled in handling regulatory submissions and documentation, possess excellent problem-solving abilities, and have experience mentoring R&D scientists. Familiarity with CAPA systems and good documentation practices will further strengthen your candidacy for this position.,

You will be responsible for performing analyses of Drug Product and Drug Substances to evaluate various test parameters as per product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. Additionally, you will compile analytical results and prepare Method Development Reports. It is essential to ensure adherence to GLP aspects in the analytical laboratory to maintain quality and accuracy in testing processes. The ideal candidate should have 0 to 3 years of experience in a similar role.,

The Quality Assurance Manager role at our organization in Bagru, Rajasthan requires a minimum of 5-7 years of experience and a Bachelors Degree (or higher) in Chemistry, Biochemistry, Food Science/Technology, Analytical Chemistry, Chemical Engineering, or related disciplines. As the Quality Assurance Manager, you will be responsible for ensuring that the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This will involve managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key responsibilities include implementing and maintaining ISO/IEC 17025:2017 QMS, managing client and regulatory audits, overseeing lab operations, safety, equipment, and records, reviewing and approving deviations, change controls, and CAPA, resolving customer complaints, and providing training on ISO/IEC 17025:2017 and quality practices. Additionally, the role requires conducting performance reviews, monitoring quality tools, and ensuring GLP compliance. To qualify for this position, you must have a Bachelors Degree (or higher) in a relevant field, 5-7 years of experience in quality assurance within a lab, strong knowledge of ISO/IEC 17025:2017 and GLP, excellent leadership, communication, and decision-making skills, as well as experience with audits, CAPA, and safety procedures. If you meet these qualifications and are ready to take on a challenging role in maintaining quality standards and compliance, we encourage you to apply for the Quality Assurance Manager position.,

Job Description: As a QA Manager at Sohan Healthcare Private Limited in Daund, you will play a crucial role in overseeing quality assurance processes to ensure compliance with regulatory requirements and maintain the highest standards of quality. Your responsibilities will include conducting internal audits, managing quality control activities, and implementing quality improvement initiatives. Your expertise in Quality Assurance, Quality Control, and Regulatory Compliance will be instrumental in ensuring the smooth functioning of the quality assurance processes. Your strong analytical and problem-solving skills will be put to use to identify areas for improvement and implement necessary changes. Attention to detail and accuracy are essential qualities that you will bring to the role, ensuring that quality assurance processes are executed effectively. Your excellent communication and interpersonal skills will enable you to collaborate effectively with cross-functional teams and stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field is required for this role, along with experience in conducting internal audits and implementing quality improvement initiatives. Knowledge of GMP, GLP, and other relevant quality standards is essential. Certification in Quality Management or Quality Assurance would be a plus. This is a full-time on-site role that offers the opportunity to work in a dynamic environment and contribute to the success of Sohan Healthcare Private Limited.,

Responsible for day-to-day activities of Quality Control, prepare and maintain documentation as per cGMP norms. Working Experience on HPLC is must Coordinate with other depart for smooth running of plant Capable of handling external Audits Required Candidate profile Min Exp 2 to 10 years in Quality department of a reputed pharmaceutical Company Knowledge of working in GMP Co. MS Office (MS Word & MS Excel) / ERP software. and good time management skills Perks and benefits Performance linked incentive & annual bonus extra

Prepare and review study protocols, reports, and SOPs Ensure compliance with GLP, GDP, and regulatory guidelines Collaborate with cross-functional teams for data collation Maintain document version control and audit readiness Ensure clarity, accuracy, and consistency in technical writing Support regulatory submissions and internal audits Review raw data for completeness and integrity Track timelines to ensure on-time document delivery

Division Department Sub Department 1 Job Purpose Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards. Key Accountabilities (1/6) Analyse and review samples based on work allocation to meet the service level agreement Analyse samples as per priority and work allocation Review the data as per respective specification, Microbiological Methods and results obtained Prepare, review and submit reports to Team leader within stipulated timelines in order to support individual sample release within stipulated timelines to achieve SLA Key Accountabilities (2/6) Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases Initiate investigations and take necessary corrective and preventive actions Investigate incidence & lab error on priority basis so that batch release timely and issues are not recurring Key Accountabilities (3/6) Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries Review reports as per cGMP & GDP for compliance to GLP Ensure no GMP / regulatory concern are raised by adhering to SOPs and following procedures Key Accountabilities (4/6) Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same Maintain equipment and instruments optimally to ensure no incidences or non-compliances occur due to malfunctioning of equipment/ instruments Key Accountabilities (5/6) Key Accountabilities (6/6) Major Challenges Availability of Validation records of analysis samples becomes a challenge in cases where validation is performed on other sites. Material and resource availability becomes a challenge due to conflicting priorities between labs and coordination between analysts which makes it tough to fulfil SLA Key Interactions (1/2) Units for receiving specification, documents, protocols, area availability etc. (daily) QA/QC for product sample release (daily) Stores for procuring materials (need basis) Communicate if any observation find on the specification. Key Interactions (2/2) CQA for procuring pharmacopial guidelines (need basis) Dimensions (1/2) Review and release approximate 15 MLT reports on daily basis to achieve the SLA. Review and release approximately 15 sterility batches on weekly basis and 15 bio load samples. 50 Water Samples analysis and release 10 Technical Information Sheets for swap analysis 6 Autoclave & DHS Operation 200 locations released on daily basis for Environmental monitoring Dimensions (2/2) Key Decisions (1/2) Daily Media and Plates requirement (to Team Leader Microbiology) Key Decisions (2/2) Education Qualification M. Sc (Microbiology) Relevant Work Experience 1-5 years experience for analyst and 3-7 years for reviewer in Microbiology Good knowledge of Microbiology, skill to perform assigned task, communication in English

As a member of our team, your primary responsibilities will include the development and validation of methods for Assay, Dissolution, and related substances. You will also be responsible for the calibration of analytical instruments to ensure accurate and reliable results. Conducting routine and stability samples analysis of OSD formulations will be a key part of your role. To excel in this position, you must possess a good quality mindset and have a thorough understanding of GLP requirements. Your ability to write technical reports and prepare power point presentations will be essential for effectively communicating your findings and recommendations. Join us in this dynamic role where you will play a crucial part in ensuring the quality and accuracy of our analytical processes.,