Senior Executive Quality Assurance : 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 • Robust 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/A In 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) Experience Level Executive Level