Executive QA Documentation

Position Title: Executive QA Documentation **Qualifications & Experience** Educational Qualification * Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences, or a related discipline. **Experience** * 1–5 years of relevant experience in Pharma Quality Assurance / Documentation **Skills & Competencies** * Strong knowledge of cGMP, GDP, and Quality Systems * Hands-on experience with batch documentation and document control systems * Good understanding of APQR preparation and regulatory expectations * Strong analytical, organizational, and coordination skills * Effective communication and cross-functional collaboration abilities * Attention to detail and commitment to data integrity Key Responsibilities  **Review of Master Documents** * Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records to ensure accuracy, regulatory compliance, and alignment with approved specifications and process related changes. * Coordinate with Production, QC, and Regulatory Affairs for timely updates and approvals. **Annual Product Quality Review (APQR)** * Prepare, compile, and review Annual Product Quality Reviews (APQRs) in line with regulatory expectations. * Support identification of improvement opportunities and follow-up of CAPAs arising from APQR findings. **cGMP Training Coordination** * Coordinate and monitor cGMP and quality-related training programs for site personnel. * Maintain trainingschedules, records, and effectiveness assessments. **Archival & Records Retention** * Manage the archival room and document storage systems for controlled and historical GMP documents. * Ensure secure storage, easy retrieval, retention compliance, and protection against unauthorized access or damage. * Support audits and inspections by ensuring availability of archived records.