Specialist, PQR
Date: 18 Mar 2026
Location: Andheri (East), IN, Mumbai 400
Company: AdvanzPharma
JOB DESCRIPTION
Job Title: Specialist - Product Quality Review
Department: Quality
Role Holder:
Reports to: Manager – Product Quality Review
Main purpose of role:
- To ensure effective Product Quality Reviews/Annual Product Review are performed on all products manufactured for and on behalf of ADVANZ PHARMA.
Key responsibilities (In Points):
- To perform PQRs / APRs in timely manner and confirm that it meets regulatory requirements.
- To assist the Manager- Product Quality Reviews in designing annual Product Quality Review plan.
- To liaise with contract manufacturing site, packaging site to ensure the timely availability of PQR/APR.
- To assess the PQR/APR provided by the manufacturers in a timely manner and confirm they meet with the procedural and Regulatory requirements.
- To prepare API supply chain maps with respect to data arranged from Global Supply Chain Unit.
- To ensure that the relevant QP is provided with a copy of the latest PQR/APR with a summary result.
- To ensure the PQR/APR database is regularly updated and effectively maintained.
- Timely review of CAPAs identified as a result of PQR/APR review and conduct timely meetings with relevant department for completion of these CAPAs.
- To ensure an effective procedure is followed for assigned objectives.
- To ensure the PQR/APR procedure thoroughly followed and suggest the improvement.
- To provide support during inspections by competent authorities.
- To prepare monthly metrics report.
- To participate in self-inspection process.
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Requirement |
Essential |
Desirable |
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Qualifications: |
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Bachelor’s degree in Pharmacy or Life Science |
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Post graduate qualification in a relevant scientific discipline |
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X |
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Experience & Competences: |
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Experience in Pharmaceutical Quality Control and Quality Assurance in manufacturing or testing |
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3-5 years’ experience in a Pharmaceutical organization |
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X |
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Has experience of working in a virtual company environment |
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X |
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Experience in analytical techniques, analytical validation |
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X |
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Knowledge of electronic document management systems and their use in regulated environment |
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X |
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Experience with competent authorities inspection |
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X |
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Knowledge & Skills: |
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Competent use of grammatically correct written and spoken English |
X |
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Knowledge of MS office (Word, Excel, Outlook, PowerPoint), Adobe Acrobat and web applications |
X |
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Knowledge of European Regulations, GMP and QMS |
X |
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Knowledge of Technical aspects of product manufacture including quality control and compliance |
X |
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Ability to check, analyse and investigate scientific data and information provided in the registered document and PQR/APR |
X |
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Decision making and problem-solving skill |
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X |
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Personal Qualities: |
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A methodical, hardworking individual |
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Specific awareness of Company’s culture and objectives |
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Organisation and time management skills |
X |
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Attention to details |
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Proactive |
X |
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Date Position Effective: |
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Job Holder Name:
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Line Manager Name:
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Job Holder Signature:
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Line Manager Signature: |
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Date: |
Date: |