Zentiva Hiring For PQR & PQE Specialist

Zentiva is hiring for the position of PQR & PQE Specialist in Ankleshwar, India. The role focuses on Product Quality Review (PQR) preparation, compilation, data verification, first-level review, documentation, trend support, action tracking, and inspection readiness within the Quality organization.

Job Details

Position: PQR & PQE Specialist

The Product Quality Review Specialist is responsible for preparing, compiling, reviewing, and maintaining PQR documentation. The role involves collecting information from various quality and business systems, verifying data completeness and consistency, coordinating with stakeholders, maintaining trackers, and supporting PQR inspection readiness.

Responsibilities

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 required PQR sections are accurately and completely populated.
• Maintain traceability between source data and PQR content.
• Ensure integrity, completeness, and traceability of source data.
• Participate in process improvement, harmonization, and digitalization initiatives within the PQR workstream.
• Support 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 the availability of required PQR data.
• Identify missing, inconsistent, or unclear information and raise queries with relevant stakeholders.
• Maintain the PQR tracker 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.
• Escalate potential adverse trends or quality signals to the PQR Expert or Manager.
• Ensure PQR recommendations are clearly documented and transferred to relevant action tracking systems.

Compliance & Documentation

• Follow GDP principles, approved SOPs, work instructions, and data integrity expectations.
• Maintain 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.

Eligibility & Qualifications

Candidates should have:

• A Technical University Degree; degrees in health, pharma, technical, or chemical areas are advantageous.
• 3 to 6 years of experience in pharmaceutical QA, QC, production QA, PQR/APQR, documentation, QMS, or regulatory quality.
• Good understanding of GMP, GDP, data integrity, and quality documentation.
• Strong understanding of international standards and regulatory requirements from Health Authorities.
• Experience with audits and inspections is highly desirable.
• Strong experience in GxP-related areas including:
  • Change control
  • Deviation
  • Quality processes
  • Document management

Required Skills

• Organizational and analytical skills.
• Quality management and continuous improvement knowledge.
• Critical thinking and risk-management capabilities.
• Risk-based approach.
• Proactive and solution-oriented approach.
• Ability to work effectively in a matrix and cross-functional environment.
• Ability to work independently with minimal supervision.
• Ability to make and communicate difficult decisions.
• Strong written and verbal communication skills in English.
• Self-awareness and willingness to develop strengths and identify improvement opportunities.

Application Details

Position: PQR & PQE Specialist
Location: Ankleshwar, India
Job Type: Full-time
Job Requisition ID: R2469720