199 Glp Jobs - Page 2

Role & responsibilities Lead and manage the Quality Control team to ensure timely and accurate analysis of finished products (OSD & Injectables). Review and approve analytical reports, ensure compliance with GLP and cGMP standards. Oversee operations involving HPLC, GC, UV, IR , and other sophisticated instruments. Ensure proper implementation of MPCL and maintain all microbiological standards in compliance with regulatory guidelines. Handle all regulatory audits (USFDA, MHRA, WHO, etc.) and prepare necessary documentation. Manage OOS/OOT investigations and ensure CAPA implementation. Coordinate with cross-functional teams (QA, production, regulatory affairs) to ensure product quality. Train and mentor junior staff; ensure continuous skill development within the QC team. Manage documentation including SOPs, specifications, STPs, and logbooks. Preferred candidate profile B.Pharm / M.Pharm / M.Sc in Chemistry or equivalent. 12 15 years of relevant experience exclusively in the pharmaceutical industry (OSD & Injectables) . Strong knowledge of GLP, MPCL, and finished product QC . Proven team leadership and people management skills. Experience in handling regulatory inspections and audits. Good communication and documentation skills.

Job Summary: Perform and report the analysis of In-Process samples, finished products, Stability samples and Cleaning Validation. Job Responsibilities: To ensure timely completion of analysis and data completion for the same. To be responsible for all activities in the Quality Control Laboratory, including cGLP, documentation and implementation of departmental quality systems. To perform the in-process/finish product/stability testing of laboratory Batches, Commercial batches, other stability samples and Cleaning validation. To Prepare Stability Trend Reports for Laboratory samples. To collect and maintain various laboratory samples. To generate and maintain records related to laboratory samples. Works as a member of a team to achieve all outcomes. Performs all work in accordance with all established regulatory and compliance and safety requirements. Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion. To assist the Senior Analyst / Team Leader/Group Leader in the day-to-day functioning of the Quality Control Laboratory. Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies. All other duties as assigned. Job Requirements: Education M.Sc\BPham or any equivalent degree Knowledge, Skills and Abilities Effective command over verbal and written communication with good interpersonal skills. Command on Microsoft-Office (Word, Excel). Able to prioritize the tasks. Best in effective planning of work activities to meet the time lines. Experience Minimum 2 to 4 years of experience in GMP regulated pharmaceutical industry.

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications M. Pharm (Pharmaceutical Analysis) / M. Sc Chemistry Additional Information Experience level : 0 - 2 years in Bio/Pharmaceutical Analysis Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Eurofins Scientific is an international life sciences company that provides a wide range of analytical testing services to clients across multiple industries. From food and pharmaceuticals to environmental and cosmetic products, Eurofins ensures safety, authenticity, and accuracy. With a global presence and over 900 laboratories, Eurofins is a leader in food, environmental, pharmaceutical and cosmetic product testing, as well as in genomics, clinical studies support, and other specialized diagnostic testing. Position Summary: Ensuring that the client receives quality data by reviewing laboratory data for accuracy, clarity, and adherence to GMP and/or GLP regulations Essential Duties and Responsibilities Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned Qualifications Basic Minimum Qualifications: To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required. Education/Experience: A masters degree in microbiology Additional Information Experience level :02 years of pharmaceutical experience preferred. Key Candidate Attributes: Self-motivation; excellent quality of work and attention to detail Ability to communicate effectively with coworkers and internal/external clients Ability to learn new tasks quickly and to move easily from task to task Ability to handle prioritization and multiple tasks simultaneously Ability to use a personal computer and learn necessary programs Good communication skills (oral and written) Organizational ability and good judgement Science background/education and/or laboratory experience

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Applies GMP/GLP in all areas of responsibility, as appropriate Demonstrate and promote the company vision Regular attendance and punctuality Read and understand analytical procedures Review documentation, generated data, calculated results, and final reports according to departmental, corporate, and client SOPs Gain a technical understanding of the techniques in which review is being performed Use MS Windows applications such as EXCEL, Word, Access, Outlook email Conducts all activities in a safe and efficient manner Performs other duties as assigned

Challenging. Meaningful. Life-changing. Those aren t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers. bms. com/working-with-us . Position Summary We are seeking a candidate with knowledge of clinical trials and the end-to-end management of biospecimens. You will be an independent contributor who will work closely with our Clinical Teams to develop and implement biospecimen management plan for BMS-sponsored Phase 1-4 clinical trials. Critical to this role is the ability to oversee timelines for specimen data delivery and thereby, enabling quick decision-making and ensuring BMS s continuous competitive advantage. Key Responsibilities Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision. Clinical Team member responsible for providing shipping/sample movement and management including requests, query and inventory reports, follow up active issues with vendors, prepare sample management related reports, review/prepare tracking activities (such as vendor manifests/inventories, tissue/blood match pairing, depleted/non-viable samples, loading documents to Shared Drive folders, etc. ). Independently reviews clinical study protocol providing comparison of vendor statement of work and biospecimen relevant sections and feedback with support as needed. Performs routine vendor management responsibilities. Able to request and/or access necessary vendor/system inventory files to perform specimen tracking. Able, under direction, to create biospecimen tracker using various tracking tools (MS Excel, Spotfire, Tableau or internal systems (if applicable)). Exercises judgment within policy and procedure boundaries. Troubleshoots routine problems and understands when appropriate to ask for guidance. Qualifications & Experience Minimum of 3-4 years academic, biotech, healthcare or pharmaceutical industry experience or equivalent. Basic understanding of clinical and biomedical research, GCP, GLP, CLIA, data management, risk management and regulatory issues. Demonstrated clinical trial experience, healthcare/medical/laboratory or equivalent. Vendor experience preferred (e. g. , Central Labs, Bioanalytical, Biomarker, CROs, Biospecimen Storage Vendors, etc. ). Biospecimen management experience preferred but not mandatory. Ability to effectively communicate, create and deliver presentation/information/data to knowledgeable audiences, with limited supervision. Ability to adopt a biopharma enterprise-wide and entrepreneurial mindset, to act with a sense of urgency, accountability and integrity, and to have fun along the way. Travel requirement is minimal, 0%- 5% of time, when organization requests If you come across a role that intrigues you but doesn t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. With a single vision as inspiring as Transforming patients lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms. com . Visit careers. bms. com/ eeo -accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers. bms. com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

1.Monitoring of cGMP and GLP compliance and compliance to applicable regulatory requirement and filing commitments. 2.Resopnsible for investigation of LIR (Incident / OOS/ OOE). 3.Analysed data review. 4.Analysis of Finished, In process, Process validation, Cleaning Validation samples. 5.To report any OOS/Incidence results to immediate supervisor/Head of department. Job Role : GLP Analyst Block 2 1.To perform daily verification/calibration of all quality control laboratory instruments. 2.To ensure destruction of unused solid and liquid samples, to discard left over samples. 3.To ensure all QC activities are being performed as per approved specification/ GTPs/ SOPs. 4.Laboratory chemical management. 5.Laboratory Instrument qualification.

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

"Key responsibilities: Perform analysis, report raw data, ensure data tracing, submit reports, address reviewer comments, follow GLP, report incidents/deviations, review data accuracy, provide training, and handle events as per SOP."

Position: Senior Executive/Manager - Flow Chemistry Job Grade: G11B/G11A Function: Process Engineering Sub-function: Research Development Manager s Job Title: Sr. Manager Skip Level Manager s Title: Sr. GM Function Head Title: VP Location: Gurgaon Job Summary The position is responsible for tasks related to flow chemistry, design flow chemistry setups, transfer of technology to plant for commercial production , trouble shooting of existing tech etc. Areas of Responsibility 2-8 years of Experience in flow chemistry. Have worked on Corning, VapourTech, Chemtrix, Coflore, Fixed Bed, Plug flow reactor etc. Design flow chemistry setups. Carryout the experiments in micro reactor. Convert existing batch chemistry to flow chemistry. Basic knowledge of chemical characterization, regulatory, quality guidelines and documentation. Literature search using Scifinder, Reaxys and other tools and preparing product dossiers. Transfer technology to plant for commercial scale-up. Trouble-shooting of running technologies in plant. To prepare technology transfer documents and get audited. To support in addressing regulatory queries. To ensure the compliance by following GDP and GLP in lab. Generation of intellectual properties by publishing patent/papers. To work in Team Energetic Innovative thinking Willingness to take responsibilities Travel Estimate Travel to the plants on need basis (1-3 month / year) Job Scope Geographical Scope Across API sites (domestic) Job Requirements Educational Qualification B. Tech or M. Tech in Chemical Engineering / Ph. D. Organic Chemistry Skills Knowledge of organic chemistry and flow chemistry. Experience having 2-5 year of experience in Flow Chemistry / Continuous Synthesis Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Role & responsibilities RESPONSIBILITIES Product is maintained in constant state of validation Product history is documented and available and current since transfer from development to date Continuously improving CpK (process capability)/ Ppk (Process Performance) Degree of standardization of product process. Genotoxic and elemental impuirty assessment in all APIS Nitrosamine impuirty assessment Transport risk assessment Investigation and data analysis of Customer Complaints, Recalls, Recurring Deviations and OoS, OoE Out of Specification, Out of Expectation. Success rate of Health Authorities inspections. Completeness of Reg CMC dossier Effective CAPA. Continuously improving Yield. Technical reports executed on time and with the right expectations. Preferred candidate profile Transfer OUT process Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed. Investigations/improvement on product Initiate and support investigations and improvement projects (quality, efficiency), based on the above data analysis, involving cross-functional teams Actively participate and represent their product(s) in the relevant committee (e.g. Product Stewardship Committee), where the improvements on weak point products are planned, prioritised and monitored Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables and use the output to verify critical process parameters Validation: Provide all necessary information to perform the validation documentation, align with stability expert and QC labs to organize the stability samples Supports Validation Lead and Experts to assess need and plan validations / re-validations / verifications / Annual Monitoring Batches, consulting approving and reviewing the process validation master plan, together with the Validation Lead or Validation Experts Approves both Validation Protocols and Report Testing Monograph oversight: Ensure oversight on Testing Monograph, liaising with Analytical Services to ensure consistency of content Change control: Ensure oversight of technical changes and lead end- to- end change control management related to technical issues, working cross- functionally as required. Training: Own the Training Curriculum for its Job Profile and provides the necessary training and support to new associates joining this position Regulatory Filings: Act as the interface for the site with the relevant Health Authorities for technical issues. Review and releases regulatory proposals or information required for regulatory filings. Genotoxic impuirty assessment, Nitrosamine impuirty assessment, Elemental impuirty assessment and Transport risk assessment report. Audit support: Maintain their work in inspection readiness level and to provide the necessary support in any internal or external audit Key process safety related roles and responsibilities Responsible for the safe operation of one or more processes and the appropriate training of the operators in the process. Facilitate team which carries out ZHA before introducing the process. Prepare overall plan for Integrated Management System documentation, control and its implementation within the department in close coordination with respective HODs including implementation of Olon Health, Safety & Environment system as per CHSE guidelines. As appropriate, responsible for implementation of, compliance to and governance of practices specifically prescribed to this role by the Novartis Manufacturing Manual. Perks and benefits

1. Quality Management Systems: Implementing, monitoring, and maintaining Quality Management Systems to ensure compliance with CGMP/regulatory guidelines. 2. Documentation: Reviewing and approving technical and quality documents. Required Candidate profile Should be minimum Post Graduation in Science having the work experience of about 6-7 years of experienced in FMCG company or in pharma industry.

Developing and Implementing QA Systems and Procedures: Responsible for establishing and maintaining quality assurance systems, policies, and procedures. This includes creating SOPs (Standard Operating Procedures), work instructions. Required Candidate profile Strong knowledge of cGMP and relevant regulatory requirements: This includes understanding manufacturing processes, quality control procedures, and validation requirements.

What you will do In this vital role you will the Project Management Coordinator will play a key role for the management of Research & Documents controlled documents through helping to strengthen and advance Amgens R&D Quality Management System. This role contributes to implementing strategies and to ensure excellence in R&D controlled document management. Roles & Responsibilities: As an integral team member working globally with R&D Quality team members and R&D Business Process Owners to ensure compliance with GCP regulations and other requirements: Provide technical writing and editing expertise to support the generation of robust, well-written R&D controlled documents. Coordinate workflows for R&D documents (e.g., SOPs) in controlled document management system. Oversee workflow completion, updates, tracking status, and follow-up activities. Perform Quality Checks and editing against R&D templates. Assist PM/Quality Lead with writing support during project meetings. Follow step-by-step instructions and perform repetitive tasks accurately Communicate and educate clients on R&D document processes, troubleshooting issues, and resolving complaints Supports Amgens procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity. Coordinate workflows for R&D documents (e.g., SOPs) in controlled document management system Ensures that all procedures are written clearly for the execution of Amgens GCP/GPvP/GLP research regulations within a diverse, complex, and cross-functional team of researchers. Supports the change control of business procedures in a timely manner with a focus on detail and the output of concisely written documentation. Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective GCP/GPvP/GLP quality management system What we expect of you Basic Qualifications and Experience: Masters degree and 1-3 years in Pharma and Biotechnology R&D Quality OR Bachelors degree and 3-5 years in Pharma and Biotechnology R&D Quality. Diploma degree and 7-9 years in Pharma and Biotechnology R&D Quality. 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 Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment. Complex document management in the R&D space with experience in GCP regulations. Effective communication, critical thinking and problem-solving 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. Experience within Biotech/pharmaceutical Research, including the application of Global Regulations. Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes. Independent and team work capabilities Operational and compliance-critical administrative support 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

What you will do The Quality Compliance Manager is a global role and part of the Process Quality team for the R&D Quality Organization. In this vital role you will work with a team of process-focused colleagues who work to complete Amgens Process Quality strategy, which is vital to ensuring that Amgens Research and Development Standards (SOPs and associated documentation) are adequate, clear, and up to all applicable current regulations and quality requirements. The R&D Process Quality team supports the Quality Management System (QMS) across all areas of research at Amgen, including discovery through the full clinical development lifecycle. This team ensures that all Amgens business procedures meet internal and external quality standards and are managed for optimum efficiency and effectiveness. The Process Quality team also ensures that Amgens R&D Business Process Network develops and manages fit for purpose standards (SOPs) that are continuously improved upon using quality by design (QbD), and risk management methods that include QMS analytics showing quality signals and trends. In addition, this individual will help support end users in R&D with the digital quality management system (DQMS) with queries, deviations and Corrective and Preventive Actions (CAPAs). 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. Roles & Responsibilities: This role will work both independently and in a team environment. Their primary responsibility is to support continuous improvement initiatives for R&D quality, but they will also be responsible for any other operational or strategy activities assigned. Generate and review process area Knowledge Maps (spider maps, lessons learning, and data processing techniques, stored in a graph-based database for better search, analysis, and visualization) to help determine inherent and residual risks, document risk assessments, and collaborate with Business Process Owners and Quality Leads to ensure accurate risk classification and preventive actions. Supports Amgens procedural framework so that all procedures maintain compliance to relevant laws, regulations, and internal quality standards; works to ensure that procedures maintain the ethical and safe treatment of all research subjects and that all data has integrity. Provide real-time, site-level quality oversight using analytical tools to identify trends, weaknesses, and data quality issues. Perform focused quality control checks on-site and remotely at clinical trial locations, especially key target sites. Offer independent and objective quality advice to local study teams Conduct risk assessments to inform audit site selection and pre-inspection/mock inspection visits. Support site/sponsor inspection readiness and management, including prep, conduct, response, and close-out phases. Ensures that all procedures are written clearly for the execution of Amgens research tasks within a diverse, complex, and cross-functional team of researchers. Supports incoming procedural change requests, including the assessment of changes (impact to the QMS, including traceability of changes across other document sets. Supports the work of Business Process Owners and applies risk-based strategies consistently to identify and mitigate risks towards the continuous advancement of Amgens R&D QMS. Applies industry standard methodologies for optimal (standardized and lean) procedural documentation, and the use of technology to drive an efficient and effective knowledge management system. Supports the application of process metrics (KQI, KPI - leading and lagging) and modern analytic methods across the Business Process Network in order to enable Management Reviews (periodic review by management to ensure QMS health is maintained). Collaborates with other quality professionals within R&D to support the QMS continuous improvement cycle (Plan, Do, Check, Act), including Deviation Management/ Corrective and Preventative Actions (CAPA). What we expect of you Basic Qualifications and Experience: Masters degree and 4-6 years in Pharma and Biotechnology R&D Quality OR Bachelors degree and 6-8 years of years in Pharma and Biotechnology R&D Quality. Diploma's degree and 10-12 years of years in Pharma and Biotechnology R&D Quality. 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 Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and virtual collaboration tools (e.g., Teams, WebEx) Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse R&D environment. 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. Experience within Biotech/pharmaceutical Research, including the application of Global Regulations. Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes. 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

Job Description Labware 7. LIMS implementation, Master data creation, Validation. Caluculation configurations. CSV documentations, Test Script review, Instrument integrations. LIMS trouble shooting and resolutions. QAMS activities, CCP, CAPA, Deviation investigation. Work Experience 4-7 years of experience in QC and LIMS Implementation Education Post Graduation in Analytical Chemistry or Analytical Chemistry Graduation in Pharmacy or Pharmacy Competencies Innovation & Creativity Result Orientation Collaboration Customer Centricity Developing Talent Stakeholder Management Strategic Agility Process Excellence

Responsible for maintaining and improving the Quality Management System (QMS) in compliance with ISO 13485:2016 and Local regulatory requirements (Indian Medical Device Rule). Responsible for internal audits, CAPA, change control, document control, risk management, and management review processes. Support external audits/inspections (Notified Body, regulatory, customer). Ensure compliance with applicable regulatory requirements and support quality system documentation updates. Collaborate with cross-functional teams to ensure quality and compliance across product lifecycle stages.

Division Department Sub Department 1 Job Purpose Perform sampling, execute and document the analysis of raw materials, packing materials, products assigned for testing and complete all the stability studies in order to ensure its compliance to the laid down quality parameters and predefined specifications / standards and meet SRB targets Key Accountabilities (1/6) Analyse the assigned samples and chromatographic tests for analysis by using the suitable valid procedure and calibrated instruments to ensure the compliance to the set specification / standards Perform analysis for release of RM, PM, FP water analysis and process/cleaning validation as per commitment dates Perform analysis for stability samples without any errors as per schedule Check the results of the tests performed, evaluate them against the specifications Review the TDS printed through LIMS for its completion before release Key Accountabilities (2/6) Perform all activities as per current standard procedures by referring to all approved procedures/specifications to ensure compliance to GLP and safety norms Gather all the samples for analysis by checking the consignment for sampling Gather the essentials like standards, glassware, solvents to perform the analysis as per specification Operate the instruments and perform routine/stability as per SOP and safety norms Key Accountabilities (3/6) Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic Maintain system integrity by updating documentations and deviations on CipDox while performing operations Maintain all the online documentation and timely entries and supporting documents Prepare new documents and update existing documents as per GMP requirement Key Accountabilities (4/6) Maintain and upkeep the laboratory working area by disposing off all analysed solutions and samples after review as per valid disposal procedures to ensure compliance to GLP Maintain equipment, facility and block premises as per SOP Perform validation, qualification and calibration as per schedule and update output of all activities in the systems Key Accountabilities (5/6) Provide suggestions and ideas by exploring new possibilities to achieve cost saving and work simplification Conduct operational studies to find improvement areas and implement new development projects Strive for continuous automation of processes through implementation of new processes Key Accountabilities (6/6) Major Challenges Delay in performing analysis or re-planning due to frequent changes in production plans. Overcome by conducting performance dialogues and handshakes meetings identifying priorities Delay in performing laboratory activity due to instrument breakdown. Overcome by ensuring timely availability of parts and engineers Delay in releasing the batches due to non-availability of standards, glassware, chemicals. Overcome by coordinating with CFTs and escalations Key Interactions (1/2) Unit Planning for daily release of RM,PM and FP (Daily) Site QC (Non-Routine) for essentials of analysis (Daily) CDC for specification changes implementation (Need Basis) Unit QA for non-conformances (Need Basis) Stores for inventory (Daily) Key Interactions (2/2) Service Engineer to resolve instrument related issues, breakdown (Need Basis) Dimensions (1/2) Number of FP batches released: 3-4 Number of RM analysis conducted : 3-4 Number of studies conducted for Stability samples : 10 Non-conformance OOS/OOT to be closed within 7 working days Non-conformance rate should be below 1.5% Dimensions (2/2) Key Decisions (1/2) Suggestions for improvement of QC productivity to Team Leader (Routine/Stability) Procurement of required instruments and glassware standards to Team Leader (Routine/Stability) Key Decisions (2/2) Education Qualification B. Sc. (Chemistry) or B. Pharm. Relevant Work Experience 0-3 years of experience in quality control function of a pharmaceutical organisation

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance of Akta systems, Tangential flow filtration, centrifugation etc. To involve in daily lab activities for process development and assist fellow researchers. LOCATION : Hyderabad. CTC : 4.5 LPA IMMEDIATE JOINERS ARE PREFERABLE" Interested candidates please attach your CV here. NOTE : Interviews will be face to face only ,no virtual interviews. For more details, please reach out Venkat - 9381915043

Experience: 4-8 Year Experience in manufacturing (API) as per Pharma Manufacturing GMP requirements. Responsibilities for Internal Candidates Key Roles & Responsibilities 1. Capable to handle independent projects 2. Analytical testing support to PDG synthetic group. 3. Coordinate with QA regarding method transfer, CCF and investigation reports. 4. Experience of handling of HPLC, GC, Potentiometer, Polarimeter instruments. 5. API Stability knowledge. 6. Capable to handle analytical method development, Implementation, Validation as per requirement. 7. Should have experience of Analytical method transfer to QC. 8. Experience of making documents like method transfer protocol & report, method validation protocol & report, method development report, specification, standard test procedure etc. 9. Should aware about GLP practices and 21 CFR part-11. 10. Keep the work area clean and the laboratory under controlled temperature. 11. Calibrate the instruments according to the master calibration schedule and follow GLP and SOPs. 12. Understand the safety and environmental aspect. 13. Maintain the reagents and standardize the volumetric solutions as per schedule. 14. Maintain the laboratory journals and instrument log books online. 15. Ensure compliance to Hazardous waste and chemical management. Responsibilities Qualifications Qualification : M.Sc (Analytical Chemistry), (Chemistry) & (Organic Chemistry)

Job Description Responsible for performing the chemical and instrumentation analysis for In-process, raw materials, packing materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule received from PPL. Responsible for performing the instrumentation like ICP-MS and LC-MS analysis for In-process, raw materials, intermediates and finished products to meet the dispatch timeline as per the monthly schedule. Responsible for performing the analytical method developments, analytical method validations, analytical method transfers and analytical method verifications by ICP-MS and LC-MS/MS. Responsible to prepare and review the protocols, work sheets and reports for method developments, method validations verifications and transfers Responsible for allotting the work to the chemist within the section. Responsible for performing the calibrations of all instruments in section as per the schedule. Responsible for maintaining all the documentation online. Responsible for maintaining the minimum stock for working standards, reference standards and impurity standards and ordering as and when required. Responsible for maintaining the minimum stocks for chemicals, reagents, glass wares and solvents required for analysis. Responsible for keeping instruments neat and clean and overall housekeeping in the section. Responsible for review of analytical data, calibration data, qualification data Responsible for keeping all instruments within the calibrated status. Responsible to do the analysis, review and release on time to support the production Responsible for reducing the lab incidences, repeat analysis and no Data Integrity issues. Responsible for real time data monitoring. Responsible for reviewing the analytical data received from external laboratory. Responsible for maintaining all the calibration certificates, qualification certificates, standard weight certificates and working/reference standard certificates. Responsible for maintaining the consumption records and traceability of working/reference standards. Responsible for OOS investigations, OOT, OOC and deviations investigations and CAPA implementations Responsible for review of SOPs , test procedures and specifications Responsible for providing the training on GLP/GMP to the employees working the section. Responsible for releasing the batches timely manner to achieve the site requirement. Responsible for preparing the COAs as per the customer requirement Responsible for approving/rejecting the batches in SAP Responsible for Controlling the cost and operate within the approved budget. Responsible for maintaining the instruments in working condition and reduce the breakdown time of instruments. Responsible for carrying out the analytical method transfers. Responsible for keeping the critical spare parts of the instruments. Responsible for Safe working conditions and clean environmental practices. Responsible for usages of required safety appliances in the section. Responsible for SFTI. Responsible for coordination with QA/Production/PPIC/Warehouse/TSD for smooth dispatches Responsible for training the contract persons and helpers on glassware cleaning. Responsibilities Qualifications Bachelors degree

Career Category Operations Job Description Join Amgen s Mission of Serving Patients At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Quality Compliance Manager - Process Excellence, Continuous Improvement & Innovation What you will do 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. Diploma Degree and 10-12 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 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 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. 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. Apply now and make a lasting impact with the Amgen team. careers. amgen. com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation. .

Role & responsibilities 1. Routine and Stability analysis of development batches. 2. Analytical support for development of new or existing APIs. 3.Analytical method development and validation of raw materials, intermediates, finished APIs, under close supervision of senior analyst. 4.Qualification, Calibration and maintenance of analytical instruments. 5.Perform Calibration of analytical instruments and online documentation as per GDP requirement. 6. Preparation / Review of test method specification, method development protocol, method development report and analytical reports. 7. Work as per Good Laboratory Practices (GLP). 8. Maintaining log books, column usage cards and calibration records. 9. Following safety in the laboratory premises by using personal protective equipment and guiding to the subordinates to follow safety norms.

We are seeking a highly skilled and detail-oriented Food Technologist to join our R&D team at DS Group. The ideal candidate will play a critical role in analyzing food materials, developing new products, ensuring regulatory compliance, and maintaining proper documentation in line with industry best practices. Key Responsibilities: 1. Food Material Analysis & Laboratory Practices 2. New Product Development & Nutritional Analysis 3. Regulatory Compliance & Food Safety Standards 4. Documentation & Record Keeping