24 Aug
|
Pfizer
|
Ahmedabad
Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering safe and effective products to patients. Our science and risk-based compliant quality culture is both versatile and innovative, always putting the patient first. Your contributions will be vital and will have a direct impact on patient care, ensuring we deliver on our promise of quality and safety.
What You Will Achieve
In this role, you will:
- Overall responsibilities for quality assurance compliance at the Zydus Hospira Oncology Private Limited (ZHOPL) site and Pfizer Quality & ensure sustainable GMP compliance for Pfizer Products manufactured at ZHOPL site as per Quality agreement.
- Batch record review and release authorization compliance functions:
- Responsible for review and authorize the packed batch lot(s) for distribution in respective market from ZHOPL.
- To be part of SQRT as needed for any Batch related issue discussion.
- Regulatory impact assessment for all types of change related to Pfizer products
- Responsible for Review and approval of Change controls at ZHOPL as per the Pfizer requirements.
- Responsible for performing the SCNM (Site Compliance Network Member) activities at ZHOPL and create the PAC and PCF in the PDM systems.
- Responsible for the review and approval of submission package as per procedure REG-459.
- Review BoH Queries & response and compendial/scientific data changes
- Responsible for review and approval for NPL assessment and dossier handover to ZHOPL
- Complaint Management for Pfizer Product
- To coordinate and ensure that ZHOPL comply with the requirements for managing complaint.
- To review and approve the ZHOPL complaint investigation reports and upload investigation reports in the Pfizer electronic complaint database.
- Support for activities including co-ordination committee meeting and share the applicable information/ distribution details to site & & Pfizer market action leader function during market action and mock recall activity.
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📌 Associate manager (Ahmedabad)
🏢 Pfizer
📍 Ahmedabad