Executive QA Documentation

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.

Requirements

• 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

Additional Information

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.

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Company Intel

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