Executive - Quality Assurance

• 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