Use Your Power for Purpose
Every day, everything we do is driven by an unwavering commitment to delivering secure and effective products to patients. Our quality culture, which is both science and risk-based, is designed to be flexible, innovative, and customer-oriented. Whether your role involves development, maintenance, compliance, or analysis through research programs, your contribution is crucial and will have a direct impact on patients. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a meaningful difference in the lives of those we serve.
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 at & 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.
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