- 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 function within QSSC is responsible for PQR planning, preparation, compilation, review, trend evaluation, process capability assessment, action tracking, and inspection readiness support. Final product quality assessment, approval, and regulatory accountability remain with the applicable site or local Quality organization.

Main Accountabilities and Duties

- PQR Preparation Compilation
- Prepare and compile PQR sections using approved templates, checklists, and source documentation.
- Collect data from sites, CMOs, ESO, affiliates, Regulatory Affairs, Quality Systems, SAP, EDMS, Quality Forward, LIMS, and other approved systems.
- Ensure all required PQR sections are populated accurately and completely.
- Maintain traceability between source data and PQR content.
- Ensure integrity, completeness and traceability of source data used for PQR preparation and review.
- Participate in process improvement, harmonization and digitalization initiatives within the PQR workstream.
- Ensure timely upload, routing, and archival of PQR documents in eDMS.





- Data Verification First-Level Review

- Perform first-level completeness and consistency checks on PQR data.
- Verify availability of required data related to contents per PQR GUI
- Identify missing, inconsistent, or unclear data and raise queries to relevant stakeholders.
- Ensure PQR tracker is updated with current status, open questions, due dates, and action status.

- Trend Support

- Perform first-level review and analysis of quality trends related to complaints, deviations, CAPA, stability data and process capability, escalating significant observations to the PQR Expert or Manager
- Escalate potential adverse trends or quality signals to PQR Expert/Manager.
- Ensure PQR recommendations are clearly documented and transferred to relevant action tracking systems.
- Compliance Documentation
- Ensure all PQR activities follow GDP principles, approved SOPs, work instructions, and data integrity expectations.
- Maintain complete audit trails and communication records.
- Support inspection readiness by preparing document packages and retrieving PQR records, trackers, and evidence.

- Communication Follow-up

- Follow up with sites, affiliates, ESO, CMOs, and internal functions for missing data or pending responses.




- Escalate delays or repeated data quality issues to the PQR Manager.
- Participate in operational PQR review meetings and backlog tracking discussions.

Qualifications

- 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.
- Robust capacity for working independently with minimal supervision.
- Ability to communicate difficult decisions, associated with strong written and verbal communication skills. (English language in writing and speaking)
- Self-awareness, willingness to further develop own strengths and explore opportunities for improvement.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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