Associate Manager - Quality Assurance

What You Will Achieve In this role, you will: Evaluate and review commercial drug batches to ensure compliance with established specifications. Ensuring Zero Defect Technology transfer for new product transfers into site. Quality Support and review of Scale-up, pilot bio batches and exhibit beaches to meet regulatory expectations. Reviews of Process validation protocols and reports to meet regulatory expectations. Review of Optimization Report /Technology Transfer Report, Analytical Data Sheet and Stability Data. Responsible to manage New Product Introduction (NPI) projects. Review and approval of Project validation protocols, QRM’s, Cleaning validation protocols and reports, process validation protocols & reports, Filter validation protocols & reports. Review of Analytical Method Transfer and method validation Reports and ensuring the key changes mentioned in the other transfer sites. Continuous improvement of templates for presentations, timelines, trackers, and other tools, Review , approval and ensure the compliance of SOPs related to technology transfer . Review and approval of validation protocols , PRQs and PR’s to ensure validation life cycle . Support production related documents review and approvals Approve investigations and change control activities to maintain compliance with configuration management policies. Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts. Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed. Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards. Here Is What You Need (Minimum Requirements) Qualification : B.Pharm /M. Pharm/M.Sc Experience : 6 to 7 years of experience in sterile injectable technology transfers/ quality Assurance /validations. Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards Strong critical thinking skills Ability to work effectively within own team and interdepartmental teams Good working knowledge of Microsoft Excel and Word Proactive approach to problem-solving 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

The Associate Manager will oversee commercial drug batch evaluations, technology transfers, and process validation to ensure compliance with global regulatory standards. They are responsible for managing new product introduction projects, approving quality documentation, and investigating deviations to maintain cGMP compliance.

Candidates must hold a B.Pharm, M.Pharm, or M.Sc degree and possess 6 to 7 years of experience in sterile injectable technology transfers, quality assurance, or validations. A solid understanding of GxP regulations and strong critical thinking skills are essential for this role.

• Quality assurancePreferred
• Microsoft ExcelPreferred
• Microsoft WordPreferred
• Project managementPreferred

Identified from the job description. Confirm important requirements above.

• Quality Assurance
• Technology Transfer
• cGMP
• Regulatory Compliance
• Process Validation
• Cleaning Validation
• Analytical Method Transfer
• Change Control
• Deviation Investigation
• Sterile Injectables
• QRM
• SOP Management
• Microsoft Excel
• Microsoft Word
• Critical Thinking
• Project Management
• Current Good Manufacturing Practices (cGMPS)
• Method Validation
• Validation Protocols
• Analytical Method
• Artificial Intelligence
• Good Manufacturing Practices
• Configuration Management
• Continuous Improvement Process
• Problem Solving
• New Product Development
• Presentations
• Quality Management
• Timelines
• Templates
• Investigation

• Healthcare
• Manufacturing
• Science & Research
• Management & Leadership
• Quality Assurance Manager
• Management and Organization Analysts
• Quality Control Systems Managers
• Industrial Production Managers

Minimum education

Bachelor’s degree

Minimum experience

5+ years

Posting language

English

Working hours

40 hours per week