Quality Assurance Job at Pfizer | MPharm Graduates Apply Now for the Associate Manager Role
Pfizer is seeking an experienced Associate Manager – Quality Assurance to join its team in Chennai, India. In this role, you will ensure compliance, data integrity, and adherence to cGMP standards across product development, analytical data review, and sterile manufacturing processes. If you’re passionate about maintaining the highest standards of pharmaceutical quality and regulatory compliance, this Quality Assurance Job offers a rewarding opportunity to make a global impact.
- Position: Associate Manager – Quality Assurance
- Location: Chennai, India
Role Summary:
As an Associate Manager in Quality Assurance, you will be responsible for reviewing product development documents, analytical data, chromatographic records, and instrument qualification data. You will ensure data integrity compliance, adherence to SOPs, and conformance to 21 CFR Part 11 requirements. This role also includes performing system audit trail reviews and supporting inspection readiness across QA functions.
Key Responsibilities of Pfizer Careers:
- Review analytical and product development data for accuracy and integrity.
- Ensure compliance with data integrity (DI) and ALCOA principles.
- Conduct periodic system audit trail reviews to maintain regulatory compliance.
- Collaborate with global business line (BL) and operations quality (OQ) teams to meet objectives.
- Maintain knowledge of ICH guidelines and regulatory expectations for sterile product development.
- Support microbiology method development related to sterility, BET, and CCIT testing.
- Participate in the qualification and validation of instruments and filtration systems.
- Review analytical method validation data and perform statistical evaluations.
- Support internal audits, regulatory inspections, and continuous improvement initiatives.
- Ensure compliance in laboratory practices and documentation review.
Required Qualifications:
- Master of Master of Pharmacy.
- Relevant experience in analytical data review, technology transfer, and cGMP sterile manufacturing.
- Strong understanding of 21 CFR Parts 210 and 211, ICH guidelines, and PDA technical reports.
- Proficiency in MS Office (Excel, Word, PowerPoint).
- Excellent communication, analytical, and time management skills.
Work Environment of the Pfizer Careers:
This role is based on-premises at Pfizer’s Chennai facility. The ideal candidate will thrive in a structured, compliant, and collaborative work environment, contributing to Pfizer’s commitment to quality and patient safety.
Equal Opportunity Statement:
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity laws. We celebrate diversity and are committed to creating an inclusive workplace for all employees.
