Role at a glance
- Job function
-
Manufacturing & Skilled Trades Quality Assurance & Quality Control
- Salary
- Not Disclosed
- Location
- India, Vizag
- Work arrangement
- On-site
- Employment
- Full-time
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About the role
Original posting provided by Pfizer
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:
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
About the company
Pfizer
Large Enterprise
Pfizer is a global biopharmaceutical company dedicated to the discovery, development, and manufacturing of innovative healthcare solutions. With a strong focus on improving lives through medications and vaccines, Pfizer has played a significant role in addressing various health challenges, including infectious diseases, chronic illnesses, and rare conditions. The company emphasizes research-driven approaches and collaborative efforts in its mission to enhance global health and empower patients through cutting-edge science and technology. Through its commitment to high standards of safety and efficacy, Pfizer continues to shape the future of medicine.