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