Position title: PQR & PQE Specialist
REQUIRED QUALIFICATIONS, EXPERIENCE & SKILLS
• Technical University Degree (health, pharma, technical, chemical areas are advantage)

• 3 to 6 years in pharmaceutical QA, QC, production QA, PQR/APQR, documentation, QMS, or regulatory quality experience.
• Good understanding of GMP, GDP, data integrity, and quality documentation.
• Strong understanding of international standards and regulatory requirements from Health Authorities. Audits and inspections experience highly desirable.
• Strong experience in area of GxP related to change control, deviation, quality processes and document management.
• Organizational and analytical skills associated with proficiency in quality management and continuous improvement.
• Critical thinking ability and risk management and risk- based knowledge and approach.
• Ability in partnering with a proactive and solution- oriented approach.
• Ability to work effectively in a matrix cross-functional environment.
• Strong capacity for working independently with minimal supervision.





• Ability to make & communicate difficult decisions, associated with robust written and verbal communication skills. (English language in writing and speaking)

• Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.

Generic Job Statement:

The Product Quality Review Specialist is responsible for preparation, compilation, first-level review, data verification, tracker maintenance, and documentation support for Product Quality Reviews. The role supports timely and compliant PQR execution for affiliates, sites and CMOs, under defined QSSC procedures.

The Specialist ensures PQR inputs are complete, traceable, accurate, and aligned with approved templates and applicable GMP expectations. The role supports PQR review activities by preparing structured review documentation, identifying missing information, coordinating with data providers, and tracking actions to closure.

The PQR

📌 PQR & PQE Specialist (Ankleshwar)
🏢 Zentiva
📍 Ankleshwar