Use Your Power for Purpose
Pfizer is driven by an unwavering commitment to delivering secure and effective products to patients. Our science and risk-based compliant quality culture is both flexible 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:
• Ensure that the electronic Batch Record/manual batch record Audit items are complete / approved per applicable policy/procedure.
• Ensure Expiration Date of the product/batch as per Marketing authorization specified.
• Ensure that all investigations are closed and disposition against the specified batches.
• Responsible for tracking of Quality restrictions/holds.
• Ensure adherence to Safety Procedures/GMP & GDP Practices.
• Interface with necessary plant disciplines to facilitate the accumulation, review, correction, and release of manufactured lots.
• Participate in and take responsibility for workplace environment,
health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.
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Here Is What You Need (Minimum Requirements)
• B.Pharma, M.Pharma or MSC with 8-10 years of experience in Manufacturing Quality/Quality Control/ Production or in Quality Assurance of a pharmaceutical manufacturing facility.
• Sterile injectable experience
• Fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries. Advanced/well-developed skills and knowledge within a specific professional discipline involving the integration of theory and principles with organizational practices and precedents.
• Excellent technical writing, communication, and presentation skills
• Proficiency in Microsoft Office, Microsoft Project, and Statistical Software
• Experience in preparing and participating in audits and inspections