PQR & PQE Specialist
AnkleshwarFull-time3–6 yrsPosted over a month ago
Mid-level pharma role at (0707) Zentiva in Ankleshwar. Needs 3+ years and a B.Tech or B.E..
About the role
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. Audits and inspections experience highly desirable. Organizational and analytical skills associated with proficiency in quality management and continuous improvement.
What you'll do
- Responsible for preparation, compilation, first-level review, data verification, tracker maintenance, and documentation support for Product Quality Reviews
- Responsible for PQR planning, preparation, compilation, review, trend evaluation, process capability assessment, action tracking, and inspection readiness support
- 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
What you need
- GMP
- Regulatory affairs
- Pharmacovigilance
- Documentation
- Safety management
- ISO 9001
Good to have
- SAP
- SOP writing