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