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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.
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:
- Evaluate and review clinical and commercial drug batches to ensure adherence to specifications and identify deviations from standards in manufacturing and packaging processes.
- Approve investigations and change control activities to maintain compliance with configuration management policies.
- Lead people, technology, and financial resources, and share knowledge actively across the unit.
- Identify potential improvements in processes or products.
- Manage the performance of both direct and indirect reports, and provide input to senior management decisions.
- Initiate and manage investigations, implementing corrective and preventative actions, and maintain and revise Document Control Standard Operating Procedures.
- Oversee and audit systems for comprehensive training of area personnel, assigning audit records to auditors, and provide Quality Assurance review and final approval on Investigation CAPAs.
- Ensure timely completion of investigations to support production operations, coordinate all quality functions through Pfizer Quality Systems, and supervise Aseptic Service Workers and documentation personnel.
Here Is What You Need (Minimum Requirements)
- M.Pharma / B.Pharma / MSC with 10-12 years of experience
- Sterile injectable 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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