Executive QA Documentation

Zentiva Poland; Ankleshwar; On-site; INR 500,000 - 700,000; Full time

Job summary

Zentiva in Ankleshwar (Gujarat) seeks an Executive QA Documentation to ensure accuracy and regulatory compliance of master records and APQRs. You will coordinate cGMP training, manage archival systems, and support inspections with data integrity and cross-functional collaboration.

Requirements include a Bachelor’s or Master’s in a relevant field and 1–5 years of pharma QA/documentation experience, with strong attention to detail and regulatory expectations.

Qualifications

• Bachelor’s or master’s degree in pharmacy, Pharmaceutical Sciences, Life Sciences or related field.
• 1–5 years of relevant QA/documentation experience in pharma.
• Strong knowledge of cGMP, GDP and quality systems.
• Experience with batch documentation and document control systems.
• Understanding of APQR preparation and regulatory expectations.

Responsibilities

• Review and maintain Master Batch Manufacturing Records and Master Batch Packing Records for accuracy and compliance.
• Prepare, compile, and review APQRs in line with regulatory expectations and CAPA follow-ups.
• Coordinate cGMP training programs and maintain training records and assessments.
• Manage archival/records retention and ensure secure storage and retrieval of GMP documents.

Skills

cGMP & GDP knowledge

Documentation control

APQR understanding

Analytical & organizational skills

Communication & collaboration

Data integrity focus

Education

Bachelor’s or Master’s in Pharmacy/Pharmaceutical Sciences/Life Sciences

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 training schedules, 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.

About us

At Zentiva, we provide health and wellbeing for all generations, with focus on developing, producing, and delivering high-quality, affordable medicines to more than 100 million people in over 40 countries across Europe. We have four manufacturing sites and a broad network of external manufacturing partners. Zentiva employs more than 5,400 unique talents in over 30 countries, bonded together by a commitment to the people who depend on our products every day. Visit us at www.zentiva.com