Senior Team Leader -Quality Assurance

Pfizer; Visakhapatnam; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Pfizer in Visakhapatnam is seeking a Team Lead in Quality Assurance and Control to oversee operations from solution preparation through vial/ampoule collection, ensuring compliance with cGMP and regulatory standards. You will lead a team, manage audits, drive CAPA effectiveness, and update procedures for continuous improvement, with a focus on sterile injectable manufacturing and strong leadership.

This role demands extensive experience in pharmaceutical quality operations, robust problem

Qualifications

• B.Pharma, M.Pharma or MSc required.
• 10-12 years of relevant experience in quality operations.
• Sterile injectable experience only.
• Strong leadership and people management skills.
• Advanced analytical capabilities.
• Thorough understanding of GMPs, applicable SOPs, production processes, and statistical/inspection practices.
• Excellent written and verbal communication.
• Ability to initiate CAPA and conduct root-cause analysis.
• Experience with audits and regulatory inspections.

Responsibilities

• Lead and monitor quality oversight for operations from solution preparation to vial/ampoule collection.
• Ensure procedures comply with cGMP and regulatory standards.
• Address quality issues promptly as per site requirements.
• Manage department in line with internal procedures and audits.
• Collaborate with Lead-Operations to resolve compliance issues.
• Update procedures to drive continuous improvement.
• Oversee line activities and batch record review.
• Review and approve SOPs and protocols.
• Conduct investigations and ensure CAPA effectiveness.
• Participate in site quality audits and CAPA tracking.

Skills

Leadership

People Management

Analytical Skills

Communication

CAPA

GMPs

SOPs

Production Knowledge

Audit Readiness

Education

B.Pharma

M.Pharma

MSc

Tools

Empower

Microsoft Office

Job description

Job Description

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

• 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, includingrisk 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

Requirements: