Senior Executive Quality Assurance

Job Description

Followings will be the Core Job Responsibilities of the position holder :

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 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 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) Review & Quality Assessment Critically review APQR data for Trends, Exceptions/Deviations and Outliers Highlight discrepancies between data and conclusions Support risk-based decision making 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 Compliance & Audit Readiness Ensure APQR and documentation are : Audit-ready, Traceable and structured Support internal and external audits related to APQR & Documentation systems 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