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Leads pharmaceutical quality operations for sterile injectable products, including batch review, deviation investigations, change controls, CAPAs, document control, training audits, and GMP compliance. Manages personnel, resources, quality systems, and production-support activities while approving investigations and improving processes. Requires substantial pharmaceutical experience, leadership, analytical skills, and knowledge of GMPs, SOPs, manufacturing processes, and inspection practices.
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Leads quality oversight for sterile injectable manufacturing, ensuring cGMP compliance, regulatory readiness, documentation accuracy, batch record review, SOP approval, investigations, CAPA effectiveness, audits, and continuous improvement. Manages quality personnel, partners with production operations to resolve compliance issues, and supports inspection and corporate quality standards.
Use Your Power for Purpose
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As a Team Lead, you will be at the forefront of improving patients' lives while working at Pfizer.
What You Will Achieve
In this role, you will:
Here Is What You Need (Minimum Requirements)
Bonus Points If You Have (Preferred Requirements)
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
Every day, Pfizer's unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Our dedication to quality and safety ensures that we consistently meet the highest standards, making a real difference in the lives of those we serve. As a Team Lead, you will be at the forefront of improving patients' lives while working at Pfizer.
What You Will Achieve
In this role, you will:
- Lead and monitor quality over sight for operations from Solution preparation to vial/ ampoule collection in TS block to ensure compliance with respect to cGMP systems and procedures.
- Ensure manufacturing procedures, policies and standards confirm to pre-defined regulatory standards and corporate standards.
- Ensure that when quality related issues arise, they are addressed appropriately and in a timely manner as per site requirements.
- Manage the department in compliance with internal procedural requirements and external regulatory audits.
- Work with direct reports, Lead-Operations to resolve issues with compliance and comply the cGMP standards in production area.
- Update procedures as necessary to address continuous improvement opportunity.
- Ensure on line manufacturing activities, contemporaneous documentation as per the defined procedures and batch record review.
- Review, approve, and authorize standard operating procedures, pre R approval/certification of protocols
- Conduct investigation and ensure appropriate CAPA's and effectiveness verifications.
- Involve site quality audits and identifying corrective and preventive actions.
Here Is What You Need (Minimum Requirements)
- B.Pharma, M.Pharma or MSC
- 10-12 years of experience
- Sterile injectable experience only
- People Management experience
- Advanced analytical skills
- Demonstrated leadership skills
- Quality operations technical knowledge and strong people management experience
- Effective communication skills, both written and verbal
- Thorough understanding of GMPs, applicable SOPs, production processes, and statistical/inspection practices
Bonus Points If You Have (Preferred Requirements)
- Proficiency in using data analysis computer tools and conducting statistical analysis
- Familiarity with Laboratory Information Management System Empower and Microsoft Office programs
- Strong problem-solving skills and the ability to think critically
- Excellent organizational and time management skills
- Strong collaboration and team-building skills
- Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use
Work Location Assignment: On Premise
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .
Quality Assurance and Control
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