Senior Executive Quality Assurance

Job description

JOB DESCRIPTION:Job Description Followings will be the Core Job Responsibilities of the position holder: 1. APQR Management • Preparation and review of Annual Product Quality Review (APQR) as per defined SOP timelines • Compilation of data from: • Batch manufacturing & packing records • Analytical results • Deviations, OOS, OOT, CAPA • Perform trend analysis and identify: • Process variability • Quality risks • Improvement opportunities • Ensure completeness, accuracy, and consistency of APR data • Provide recommendations and action points based on review 2. Documentation Control • Ensure accuracy, completeness, and compliance of all related quality documents • Review and control of Supporting documents related to APQR • Maintain document lifecycle. • Ensure document compliance with applicable SOPs and regulatory expectations 3. Data Integrity & Compliance • Ensure data accuracy and traceability in APQR and documentation. • Verify consistency of Analytical data, Manufacturing data and QMS records for supporting APQR • Ensure compliance with GMP documentation practices (GDP) 4. Review & Quality Assessment • Critically review APQR data for Trends, Exceptions/Deviations and Outliers • Highlight discrepancies between data and conclusions • Support risk-based decision making 5. Continuous Improvement (APQR Driven) • Identify and recommend process and product improvements • Support closure of actions arising from APQR findings • Strengthen documentation practices based on audit and review observations 6. Compliance & Audit Readiness • Ensure APQR and documentation are: Audit-ready, Traceable and structured • Support internal and external audits related to APQR & Documentation systems 7. Additional Responsibilities • Adhere to SOPs, safety practices, and COBC requirements • Perform any other documentation-related assignments as assigned Key Skills • Strong knowledge of: • APQR / PQR requirements • GMP & GDP documentation practices • Expertise in: • Data analysis and trending • Technical writing & review • Attention to detail and audit readiness mindset The base pay for this position is N/AIn specific locations, the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:EPD Established Pharma LOCATION:India > Village Mauza : Baddi ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Not specified MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)