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 flexible and cutting-edge, 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.
Supplier Quality Management
As

📌 Associate manager (Ahmedabad)
🏢 Pfizer
📍 Ahmedabad