Senior Team Leader -Quality Assurance

Job Description

Use Your Power for Purpose

Every day, Pfizers 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 CAPAs 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