About this role
- Review and ensure compliance of QC laboratory activities with cGMP, GLP and approved SOPs.
- Review analytical test reports, worksheets, specifications, methods and related laboratory documents.
- Perform QA review of raw data, analytical results and laboratory records for completeness, accuracy and compliance.
- Ensure compliance with ALCOA+ data integrity principles in laboratory documentation and electronic systems.
- Review and monitor OOS, OOT, laboratory incidents, deviations and atypical results related to QC laboratory activities.
- Ensure proper investigation, root-cause analysis and implementation of CAPA . Review and approve analytical methods, specifications, STPs, protocols and laboratory procedures as applicable.
- QA oversight of instrument qualification, calibration and preventive maintenance activities.
- Review laboratory equipment and instrument usage records, logbooks and associated documentation.
- Ensure proper handling, storage and traceability of reference standards, working standards, reagents and chemicals . Review stability study documentation and laboratory-related stability activities.
- Monitor environmental and laboratory compliance requirements wherever applicable.
- Participate in internal audits, customer audits and regulatory inspections and support preparation of laboratory-related responses.
- Ensure timely closure of deviations, CAPA, change controls and laboratory-related observations . Review and approve laboratory SOPs, formats, protocols, reports and other controlled documents.
- Coordinate with QC, Production, QA, Engineering and other cross-functional departments for resolution of quality-related issues.
- Support implementation and continuous improvement of Quality Management Systems (QMS) within the laboratory.
- Ensure personnel follow approved procedures and maintain proper laboratory documentation.
Provide training/coaching to QC personnel on GMP, GLP, documentation practices and data integrity . Ensure readiness of laboratory documentation and systems for regulatory/customer audits . Required Technical Knowledge Good knowledge of GMP, GLP and pharmaceutical quality systems . Knowledge of OSD/Formulation products and pharmaceutical analytical testing.
Understanding of laboratory documentation and data integrity – ALCOA+ . Knowledge of OOS/OOT investigation, deviations, CAPA and change control . Basic understanding of analytical techniques such as HPLC, GC, UV, Dissolution, KF, FTIR and other routine QC instruments . Knowledge of stability testing and analytical method validation/verification . Familiarity with electronic systems such as LIMS, SAP, QMS/DMS will be an advantage.
Understanding of regulatory expectations of USFDA, WHO-GMP, EU-GMP and other applicable authorities . Educational Qualification B.Pharm / M.Pharm B.Sc / M.Sc in Chemistry / Pharmaceutical Chemistry or equivalent qualification may also be considered based on experience.
Experience 2–6 years of relevant experience in QA/QC laboratory operations in a pharmaceutical formulation/OSD manufacturing plant.
Experience in laboratory QA / QC documentation review / compliance will be preferred.
- Key Competencies Good understanding of pharmaceutical quality systems Documentation and review skills Analytical and investigation skills Attention to detail Data integrity awareness Problem-solving ability Good communication and coordination skills Audit and inspection readiness Ability to work effectively with QC and cross-functional teams Preferred Experience Candidates with experience in: OSD/Formulation manufacturing QA oversight of QC laboratories Analytical data review OOS/OOT investigations Data integrity and ALCOA+ Regulatory/customer audit handling LIMS/QMS/DMS systems