PQR & PQE Specialist
Zentiva · Ankleshwar
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 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.
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 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.
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OTHER RESPONSIBILITIES
QUALITY
- Adheres to the principles of GMP in the extent related to the performed activity. Is obliged to regularly train in this policy.
- undefinedHSEAdheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System. "> ">undefinedPHARMACOVIGILANCEAll employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations. COMPLIANCE**) country specificThe employee will comply with all internal rules of the Company, mainly with the Working Order of the Company and all other internal rules specifying the provisions of the Working Order. The employee will make her/himself acquainted with the Code of Ethics (Zentiva “Code of Common Senses”) and will comply with the principles stated therein and in all related policies and other internal documents. SUSTAINABILITYAdheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars People, Partners and the Planet COMMUNICATIONS & WORKING RELATIONSHIPS InternalCommunicate with all relevant departments within Zentiva manufacturing sites, corporate functions, affiliates and Shared ServicesExternalCommunication with External suppliers.