447 Glp Jobs - Page 5

GLP Compliance. Analysis of API, Finish product, Excipient and development stability Samples. Routine support in product development. Dissolution profiling. Analytical method development for Assay, Related compound, Residual solvent and Dissolution. Partial Validation for analytical method. Preparation of SOPs. Review of analytical Data. Operation and calibration of sophisticated instruments like Dissolution apparatus, HPLC, UPLC, GC and et

Essential Functions: Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods. Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries are updated regularly. Perform LIMS entries and maintain relevant analytical records for traceability and compliance. Participate in investigations related to OOS, OOT, deviations, incidents, and laboratory errors. Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and cGMP requirements in all activities. Ensure daily laboratory housekeeping and maintain laboratory safety protocols, including use of PPE. Support review and archival of analytical records and raw data as per data integrity norms. Carry out any other assignments allocated by the QC Head or Designee. Additional Responsibilities: Assist in method verification, validation, and transfer activities as required. Support review and revision of SOPs, specifications, and analytical methods. Participate in internal and external audits by providing relevant data and documents. Train junior analysts and contract staff in safe and compliant lab practices. Ensure proper retention, reconciliation, and disposal of samples as per SOPs. Support trending and analysis of analytical data (e.g., stability trends, impurity profiles). Coordinate with production and QA teams to ensure timely testing and batch release. Highlight any instrument malfunctions or quality concerns to the supervisor promptly. Qualifications :- Education: M.Sc - Chemistry / Organic Chemistry - Preferred B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background Experience: 3 to 6 years of relevant experience in Quality Control - exclusively in API manufacturing environment Skills: Analysis of API, RM, Intermediate Samples - Intermediate to Advanced Instrumental Analysis (HPLC, GC, UV, KF, IR, etc.) - Intermediate LIMS Operation and Data Entry - Intermediate Handling and Review of Analytical Documentation - Intermediate OOS/OOT/Deviation Investigation Participation - Intermediate Good Laboratory Practices (GLP) - Advanced Good Documentation Practices (GDP) - Advanced Laboratory Safety and Compliance - Intermediate Data Integrity Principles - Advanced cGMP Awareness Specific to API Environment - Advanced.

Essential Functions: Participate in project planning and distribution of R&D tasks and responsibilities. Monitor and evaluate process verification schedules, plant verification batches, and prepare corresponding reports. Compare yield and quality trends of R&D verification batches and plant validation batches. Prepare, review, and interpret characterization reports for working standards, key starting materials (KSMs), and related substances. Prepare and verify documentation related to R&D process verification and validation batches. Support in plant-scale investigations and troubleshoot issues in coordination with plant and QA teams. Ensure timely submission of R&D and validation samples to Analytical Development Lab (ADL) and follow up for results. Coordinate sample dispatches (RM/intermediates/API) to the Ahmedabad API R&D division for further testing. Communicate with the Raks Ahmedabad API R&D team for technical discussions, project updates, and experimental outcomes. Assist in documentation related to Consent for Establishment (CFE), Drug Licenses, and regulatory submissions. Review of stability study data generated for development and validation batches. Perform and review routine verification and calibration of laboratory instruments used in process development. Review and approve documents related to process development (PD) and validation activities. Train junior staff or subordinates on lab safety, process understanding, and documentation practices. Additional Responsibilities: Ensure compliance with data integrity, GLP, and cGMP practices in R&D operations. Participate in technology transfer from R&D to the production plant and ensure smooth scale-up. Support generation of documents for regulatory filings, including development reports and protocols. Assist in root cause analysis and CAPA implementation related to process deviations. Maintain records of sample tracking, logbooks, and development experiments in compliance with QA requirements. Participate in internal and external audits relevant to R&D activities. Ensure upkeep and maintenance of R&D equipment and request calibration/servicing as per schedule. Drive continuous improvement and cost optimization in process development. Collaborate with QA/QC, Production, and RA teams for project coordination and compliance. Qualifications :- Education: Master Degree, M. Sc - Organic Chemistry - Preferred Ph.D - Chemistry / Pharmaceutical Sciences - Preferred Experience: 3 to 7 years of experience in API R&D/process development Skills: Process Development & Scale-Up - Advanced Plant Validation & Technology Transfer - Intermediate to Advanced Analytical Result Interpretation - Intermediate Process Troubleshooting - Intermediate Documentation Review (PD, Validation, Stability) - Advanced Communication with Cross-Functional & R&D Teams - Intermediate to Advanced Knowledge of Regulatory Documents (CFE, Drug License) - Intermediate cGMP, GLP & Data Integrity Principles - Advanced Instrument Calibration & Review - Intermediate Training & Mentorship - Intermediate

Essential Functions: Perform routine analysis of raw materials, intermediates, APIs, in-process samples, stability samples, and other laboratory samples as per approved specifications and methods. Carry out sampling of raw materials and packing materials in accordance with SOPs. Ensure accurate, timely, and online entry of analytical results in LIMS and relevant documentation systems. Prepare approved/rejected labels for raw materials, intermediates, and packing materials based on analysis outcomes. Conduct daily verification/calibration of analytical instruments (e.g., pH meter, balance) as per approved methods. Maintain analytical instruments in good condition and ensure logbook entries are updated regularly. Perform LIMS entries and maintain relevant analytical records for traceability and compliance. Participate in investigations related to OOS, OOT, deviations, incidents, and laboratory errors. Ensure compliance with Good Laboratory Practices (GLP), Good Documentation Practices (GDP), and cGMP requirements in all activities. Ensure daily laboratory housekeeping and maintain laboratory safety protocols, including use of PPE. Support review and archival of analytical records and raw data as per data integrity norms. Carry out any other assignments allocated by the QC Head or Designee. Additional Responsibilities: Assist in method verification, validation, and transfer activities as required. Support review and revision of SOPs, specifications, and analytical methods. Participate in internal and external audits by providing relevant data and documents. Train junior analysts and contract staff in safe and compliant lab practices. Ensure proper retention, reconciliation, and disposal of samples as per SOPs. Support trending and analysis of analytical data (e.g., stability trends, impurity profiles). Coordinate with production and QA teams to ensure timely testing and batch release. Highlight any instrument malfunctions or quality concerns to the supervisor promptly. Qualifications :- Education: M.Sc - Chemistry / Organic Chemistry - Preferred B.Pharm / M.Pharm - Acceptable for API QC with strong analytical background Experience: 4 to 8 years of relevant experience in Quality Control - exclusively in API manufacturing environment Skills: Analysis of API, RM, Intermediate Samples - Intermediate to Advanced Instrumental Analysis (HPLC, GC, UV, KF, IR, etc.) - Intermediate LIMS Operation and Data Entry - Intermediate Handling and Review of Analytical Documentation - Intermediate OOS/OOT/Deviation Investigation Participation - Intermediate Good Laboratory Practices (GLP) - Advanced Good Documentation Practices (GDP) - Advanced Laboratory Safety and Compliance - Intermediate Data Integrity Principles - Advanced cGMP Awareness Specific to API Environment - Advanced.

Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Alternate vendor evaluation etc.) - Drafting the process related reports, protocols and IOC as a part of documentation - Support of process transfers- Evaluation and support for implementation of new processes focusing on direct transfers - Preparation of Qualification /verification documents (Protocols and reports) of equipment Responsible for conducting experiments to support the manufacturing team in need for any issues or improvement in the process. Both for microbial and mammalian process - Responsible for providing shop floor support during scale up activities for engineering, CT and PPQ batches - Ensures corporate cGMP and GLP compliance of all activities performed. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. - To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. - To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Long Description 1. Perform characterization of peptides , nucleic acids-based (oligonucleotides) or other injectable drug products using High Resolution Mass Spectrometry (LC-HRMS) . Experience with QToF/Orbitrap instruments and Ion Mobility will be preferred. Additional experience in Fluorescence, particle size analysis (DLS), and other relevant techniques (e. g. SEC-MALS) are desirable. 2. Analyze and interpret LC-MS and MS/MS data for impurity profiling and characterization. Solve problems and implement new research methods through literature search, coordinate with cross-functional teams (formulation, QA, QC, regulatory, etc. ), application specialists, etc. to complete analytical tasks. 3. Prepare, review and share LC-MS data and documentation (SOP, STP, Test Reports, etc. ) in a timely manner for regulatory submissions. Follow good laboratory practices (GLP) , manage samples (collection, storage, and disposal), deviations and incidences as per established procedures. 4. Undertake routine maintenance & calibration of the analytical instruments, troubleshoot equipment malfunction often in coordination with service engineers, etc. Assist in the maintenance of the laboratory, inventory of R&D consumables, & other lab management activities from time to time Competencies Education Masters in Pharmacy or Applied Chemistry Doctorate in Pharmaceutical Technology or Analytical Chemistry Work Experience 5 - 7 years (with MPharm) or NIL (with PhD)

Job Description Planning /Analysis (Routine and stability and QBD analysis) of ongoing projects by performing analysis of various tests (e. g. Dissolution, assay, Related substances test, or as per requirement) within given Time. Analytical Method development as per current SOP/guideline wherever required. Regulatory query/Plant Query related analysis for different products. To follow Good Laboratories practice while working. Documentation and compliance and review of data generated on all analytical activities as per the GLP/GMP norms and to keep working place neat and clean. Method transfer at plant. Method equivalency, method verification, pharmaceutical equivalency analysis of Pharmacopeial method. Preparation/review of various documents like method transfer waiver, method equivalency report, cleaning validation report SOP, T-STP/FP STP etc. Coordination with team members, superiors and subordinates within the group and across all relevant groups (customers) to achieve target timelines. Procuring of columns, reagents and miscellaneous items for analytical product development/support. Whenever required give training to subordinates/colleagues to upgrade their knowledge and current requirements. Work Experience 3 to 5 years of experience Education Masters in Analytical Chemistry or Analytical Chemistry Post Graduation in Pharmacy or Analytical Chemistry Competencies

Division Department Sub Department 1 Job Purpose Provide analytical support to API R&D, Regulatory Affairs, Manufacturing units and other analytical laboratories by method development of raw materials, intermediates and final API in order to ensure the drug development is carried out as per the project timelines and adheres to all regulatory requirements Key Accountabilities (1/6) Provide method development and routine analysis under GLP environment to finalise the specification for standardization of the molecule and for final DMF submission Conduct extensive literature search Analyse raw materials, intermediates, final API, forced degradation samples, stability samples, GTI s on different analytical instruments under GLP environment Conduct Fate and Purge studies/carryover studies Perform method validation Prepare specification based on carryover studies Perform method transfer to manufacturing units for routine QC analysis Key Accountabilities (2/6) Investigate plant queries like OOS, OOT for quality control of drug substance and products in order to provide corrective actions and check samples for impurities Review the entire process to identify the source of impurities Perform degradation study to identify impurities Analyse packing material in case of leachable and extractable Key Accountabilities (3/6) Characterise final API and impurities to prepare the test or working standards for routine laboratory purpose Perform chemical and physicochemical analysis to arrive at the purity, potency and structural identity of the molecule Store impurities as per chemical properties Key Accountabilities (4/6) Conduct the incubation and perform complete analysis of stability samples to conclude the storage, shelf life and packing conditions of the final API Incubate samples at various conditions Select packing material Perform analysis of stability samples Compile trend and identify degrading impurity Evaluate shelf life of the drug substance for expiry conclusion Key Accountabilities (5/6) Keep track of the latest innovation and applications which can be used with the existing techniques to investigate / resolve critical issues Attend various webinars, conferences Evaluate various demo data s generated by instrument manufacturers at their demo labs Compare various parameters like shorter run time, solvent consumption, cost factor and environment safety Key Accountabilities (6/6) Major Challenges Changes in the Regulatory guidelines: Keeping abreast with latest regulatory guidelines and interaction with RA department Conflict regarding the priorities of samples: Interaction with cross-functional team along with the managers to prioritise the samples Delay in cross-functional activities: Interaction with immediate supervisor for clarity of responsibility Difference in instrument compatibility for analysis: Escalated to supervisors Key Interactions (1/2) API R&D/ F R & D for planning, product information and result discussion (daily) RA for regulatory discussion for Deficiency, DMF filing (as per need basis) IP or patenting any product or getting information of any known patent (as per need basis) Units for sample requirement, Method transfer, Method validations, investigations (weekly) Purchase & Imports for impurities/chemicals, instrument and Equipment (as per need basis) HR for Personal discussion and organisation rules and regulation, company policy discussion (as per need basis) Key Interactions (2/2) Outsource Labs - for external analysis (weekly) Vendors-Instruments/Equipment for service and support (as per need basis) Application specialists for application support to resolve any challenging queries (as per need basis) Dimensions (1/2) Minimal error for lab compliance and maximise output Maximise instrument utility by working in shifts Online delivery of analytical data to R&D Ensuring 100% compliance with the regulatory Meet the turnaround times for projects Publish two papers in a year Dimensions (2/2) Number of trials on various techniques during development stages Key Decisions (1/2) Result discussion for online monitoring of samples - with R&D Change in method of analysis with supporting analytical data - to the respective Group Leader Key Decisions (2/2) Education Qualification M.Sc. Chemistry /M Pharma / PGD Relevant Work Experience Minimum 1- 5 years of experience in pharmaceutical industry with analytical experience Good presentation and communication skills are preferable

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

Job Summary: We are seeking an experienced and highly motivated Biochemistry Manager to lead and oversee our biochemistry department. The ideal candidate will manage research activities, supervise laboratory teams, ensure regulatory compliance, and contribute to the strategic direction of biochemical studies and product development. This leadership role is critical in driving innovation, efficiency, and quality across our R&D or clinical operations. Key Responsibilities: Lead and manage biochemistry research and testing programs in alignment with organizational goals. Supervise a team of biochemists, researchers, and lab technicians. Plan, coordinate, and monitor laboratory activities, experiments, and project timelines. Ensure compliance with quality standards, SOPs, and regulatory requirements (GLP, GMP, FDA, etc.). Analyze and interpret biochemical data; prepare detailed reports and technical documentation. Collaborate with cross-functional teams including R&D, quality assurance, regulatory affairs, and production. Manage departmental budgets, resources, and equipment procurement. Review and approve protocols, test methods, and study designs. Identify and implement improvements in lab procedures and workflows. Mentor team members and support training and development initiatives.

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

Career Category Operations Job Description HOW MIGHT YOU DEFY IMAGINATION You ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goalsAt Amgen, our shared mission to serve patients drives all that we do. It is key to our becoming one of the world s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. What you will do 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. What we expect of you 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 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. 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, well 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 .

Roles and Responsibilities Role Overview Lead the Quality Control (QC) laboratory operations Ensure compliance with cGMP , GLP , and regulatory standards (e.g., WHO, FDA) Supervise testing of raw materials, in-process samples, and finished products Oversee stability studies , method validation , and instrument calibration Managing team and work allocation Key Responsibilities Review and approve analytical reports , COAs , and SOPs Investigate OOS/OOT results and implement CAPA Coordinate with QA, Production, and Regulatory Affairs for product release Maintain audit readiness and data integrity

Role & responsibilities 1) To perform the analysis by following cGMP, GLP, ALCO+, and safety compliance 2) To perform the sampling, testing of RM, PM, In-process, Intermediate and Finished product. 3) Participate in Investigation of deviation, Incident, OOS etc. 4) To perform all qualification activities of instrument and equipment in QC Lab. 5) Aware of calibration and operation procedure for instruments ( balance, K.F, GC. UV,refratometer and viscometer etc,) 6) Experience of QC software like Tiamo 3.0, Lab solution, SCM etc. 7) Preparation of documents ( SOP, protocol etc) related to Quality control. Kindly Send CV to mail ID, jagpal.dewal@ipca.com vishal.rankham@ipca.com

Long Description 1. Perform characterization of peptides , nucleic acids-based (oligonucleotides) or other injectable drug products using High Resolution Mass Spectrometry (LC-HRMS) . Experience with QToF/Orbitrap instruments and Ion Mobility will be preferred. Additional experience in Fluorescence, particle size analysis (DLS), and other relevant techniques (e.g. SEC-MALS) are desirable. 2. Analyze and interpret LC-MS and MS/MS data for impurity profiling and characterization. Solve problems and implement new research methods through literature search, coordinate with cross-functional teams (formulation, QA, QC, regulatory, etc.), application specialists, etc. to complete analytical tasks. 3. Prepare, review and share LC-MS data and documentation (SOP, STP, Test Reports, etc.) in a timely manner for regulatory submissions. Follow good laboratory practices (GLP) , manage samples (collection, storage, and disposal), deviations and incidences as per established procedures. 4. Undertake routine maintenance & calibration of the analytical instruments, troubleshoot equipment malfunction often in coordination with service engineers, etc. Assist in the maintenance of the laboratory, inventory of R&D consumables, & other lab management activities from time to time Competencies Education Masters in Pharmacy or Applied Chemistry Doctorate in Pharmaceutical Technology or Analytical Chemistry Work Experience 5 – 7 years (with MPharm) or NIL (with PhD)

Role: Support Analyst / Application Administrator We are seeking a highly motivated Support Analyst to provide application administration, user support, and issue resolution for computer systems used across Early Development. This role acts as a technical liaison between IT and end users, ensuring optimal system performance and compliance with regulatory standards. Key Responsibilities: Act as SME for assigned applicationssupporting users, troubleshooting issues, and managing system documentation. Handle user access control, perform audits, and maintain compliance documentation (GLP/SOP). Coordinate application deployments, upgrades, validations, and decommissioning. Collaborate with stakeholders to optimize business processes and system functionality. Maintain and review system SOPs, user manuals, and ensure audit readiness. Liaise with IT and vendors to resolve technical escalations and system configurations. Must-Have Qualifications: 23 years of relevant support or application administration experience Strong skills in MS Excel, MS Word, and business/technical applications Understanding of GxP, GLP, regulatory environments, and computer validation principles Bachelor's degree (or equivalent experience) Preferred Skills: Familiarity with NG/Pristima, Tox Reporting tools Experience supporting lab-based systems or instruments Knowledge in small project management and release control Support Analyst ,Application Admin ,IT Support, GLP Compliance ,Application Support ,SOP ,System Validation

Role & responsibilities Operate and maintain QC instruments, including HPLC, GC, UV, FTIR, Dissolution Apparatus, Melting Point Apparatus, Karl Fischer Apparatus, Auto Titration, Analytical Weighing Balance, Polarimeter, Disintegration Apparatus, pH Meter, etc. Perform analysis of in-process samples, validation, hold-time study, finished products, and stability samples as per relevant specifications. Conduct daily and monthly calibration of analytical balances in the instrumentation section. Maintain daily logs and ensure adherence to Good Laboratory Practices (GLP). Perform daily standardization of Karl Fischer reagent. Monitor and record daily temperature readings of the instrumentation room, chemical room, and refrigerator. Prepare 0.4% NaOH solution daily for the deactivation of discarded penicillin samples. Conduct regular and online analysis of cleaning (rinse & swab) samples Preferred candidate profile Hands-on experience with laboratory instruments and analytical techniques. Knowledge of GLP, GMP, and regulatory guidelines. Strong documentation and record-keeping skills. Ability to work in a fast-paced, compliance-driven environment. Attention to detail and problem-solving skills.

1. Analysis of Bulk/Granules/Intermediate/Stability & F.G 2.Sample analysis and reporting according to DCAD/DPAD 3. Raw data filling & online reporting 4.Analysis of raw material & finished product sample by HPLC & GC 5.Analysis of sample by UV-VIS Spectrophotometer & dissolution test. Preferred candidate from Pharma OSD Formulation experience only.

We are seeking a highly motivated and experienced Study Director to oversee chemical characterization studies within our research and development team. The ideal candidate will have a strong background in analytical chemistry, extensive knowledge of chemical characterization techniques, and a proven track record in managing complex projects. This position offers a competitive salary and benefits package, along with opportunities for professional growth and development. If you are passionate about advancing scientific research and thrive in a collaborative environment, we encourage you to apply. Roles and Responsibilities 1. Oversee and manage chemical characterization studies from initiation to completion, ensuring adherence to regulatory standards and internal protocols. 2. Design study plans and methodologies that are scientifically sound and aligned with project objectives, including the selection of appropriate analytical techniques and equipment. 3. Coordinate with cross-functional teams, including project managers, chemists, and quality assurance personnel, to ensure effective study execution and communication. 4. Review and approve study protocols, analytical methods, and reports to ensure accuracy, compliance, and scientific integrity. 5. Provide technical expertise and guidance related to chemical characterization, including the interpretation of analytical data and results. 6. Ensure that all studies are conducted in compliance with Good Laboratory Practice (GLP) and other relevant regulations. 7. Manage study budgets and timelines, identifying potential risks and implementing mitigation strategies to ensure successful project delivery. 8. Train and mentor staff on appropriate methodologies and regulatory requirements related to chemical characterization studies. 9. Participate in project meetings, presenting study findings and progress updates to stakeholders, and incorporating feedback into study design and implementation. 10. Maintain up-to-date knowledge of industry trends, emerging technologies, and regulatory changes affecting chemical characterization and related fields. 11. Facilitate communication with regulatory agencies as needed, providing data and documentation to support submissions and inquiries. 12. Contribute to the continuous improvement of departmental processes and methodologies, ensuring best practices are followed in study design and execution.

The Quality Assurance Manager (ISO/IEC 17025:2017) position 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. The role is based in Bagru, Rajasthan. As the Quality Assurance Manager, your primary responsibility is to ensure the lab's Quality Management System (QMS) complies with ISO/IEC 17025:2017 and other regulatory requirements. This involves managing audits, maintaining lab safety and equipment, resolving customer complaints, and driving continuous improvement. Key Responsibilities: - Implement and maintain ISO/IEC 17025:2017 QMS and ensure GLP compliance. - Manage client and regulatory audits and address findings. - Oversee lab operations, safety, equipment, and records. - Review and approve deviations, change controls, and CAPA. - Resolve customer complaints and gather feedback for system improvements. - Conduct performance reviews and monitor quality tools (ILC, PT, IQC). - Provide training on ISO/IEC 17025:2017 and quality practices. Required Qualifications & Skills: - 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. - Experience with audits, CAPA, and safety procedures.,

You will be joining Sohan Healthcare Private Limited in Daund as a full-time QA Manager. In this role, you will be responsible for overseeing the quality assurance processes, conducting internal audits, ensuring compliance with regulatory requirements, managing quality control activities, and implementing quality improvement initiatives. Your expertise in Quality Assurance, Quality Control, and Regulatory Compliance will be utilized to uphold the highest standards of quality at Sohan Healthcare Private Limited. To excel in this role, you should possess experience in conducting internal audits and implementing quality improvement initiatives. An in-depth understanding of GMP, GLP, and other relevant quality standards will be essential. Your strong analytical and problem-solving skills will enable you to address quality assurance challenges effectively. Attention to detail and accuracy in quality assurance processes will be crucial to ensure the products meet the required quality benchmarks. Excellent communication and interpersonal skills are key as you will collaborate with various teams within the organization and external stakeholders. A Bachelor's or Master's degree in Pharmacy, Chemistry, or a related field is required for this role. Additionally, certification in Quality Management or Quality Assurance would be advantageous in demonstrating your expertise in ensuring quality compliance. Join Sohan Healthcare Private Limited and contribute to maintaining the reputation of the company as a leading manufacturer specializing in Active Pharmaceutical Ingredients, Semi-finished Formulations, and Finished Dosage Forms for the global market.,

The R&D Executive at PTC - MORAIYA will be responsible for performing analysis of Drug Product and Drug Substances for various test parameters according to product development requirements. This includes Method Development of Drug Product and Method verification of Raw Materials. The role also involves compiling analytical results and preparing Method Development Reports. Additionally, the R&D Executive will be responsible for ensuring Good Laboratory Practices (GLP) aspects in the analytical laboratory. The ideal candidate should have 0 - 3 years of experience in a similar role.,