Job Description

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.