PQR & PQE Specialist

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

• 3–6 yrs of experience
• GMP
• Regulatory affairs
• Pharmacovigilance
• Documentation
• Safety management
• ISO 9001
• B.Tech or B.E.

Good to have

• SAP
• SOP writing