PQR & PQE Specialist

Overview

The Product Quality Review (PQR) Specialist prepares, compiles, first-level reviews and documents Product Quality Reviews for affiliates, sites and CMOs, under defined QSSC procedures. Final product quality assessment, approval and regulatory accountability remain with the applicable site or local Quality organization.

What you'll do

• 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, and 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.
• Perform first-level completeness and consistency checks on PQR data and verify availability of required data per PQR GUI.
• Identify missing, inconsistent or unclear data and raise queries to relevant stakeholders.
• Keep the PQR tracker updated with current status, open questions, due dates and action status.
• Perform first-level review and analysis of quality trends related to complaints, deviations, CAPA, stability data and process capability, and escalate significant observations to the PQR Expert or Manager.
• Ensure PQR recommendations are clearly documented and transferred to relevant action tracking systems.
• 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.
• 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.

What you'll need

• Technical university degree (health, pharma, technical or chemical areas are an 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.
• Strong experience in GxP areas related to change control, deviation, quality processes and document management.
• Organizational and analytical skills, with proficiency in quality management and continuous improvement.
• Critical thinking ability, with risk management and risk-based knowledge and approach.
• Ability to partner 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 and communicate difficult decisions, with strong written and verbal communication skills.
• English language proficiency in writing and speaking.
• Self-awareness and willingness to develop own strengths and explore opportunities for improvement.

Nice to have

• Audits and inspections experience.

Details

• Location: Ankleshwar, India.
• Adheres to GMP principles to the extent related to the performed activity, and regularly trains in this policy.
• Adheres to the ESMS Policy and the Health, Safety at Work and Environmental Management rules of the Company.
• Obliged to report any suspected adverse events of medicinal products, medical devices or other safety information.
• Complies with internal Company rules, the Working Order and the Code of Ethics.
• Adheres to ESG principles as detailed in the Sustainability Strategy (People, Partners, Planet).
• Communicates with relevant departments across Zentiva manufacturing sites, corporate functions, affiliates and Shared Services, and with external suppliers.