Associate Manager Quality Control

Role overview

Associate Manager Quality Control at Pfizer

In this role, you will:

Responsibilities

• Perform method transfers/ validations / method verifications to the complex analytical techniques
• Review and revise Standard Operating Procedures, analytical methods, and related documents to keep them current.
• Conduct analyses on finished products, raw materials, and components, including data entry, review, and approval in a computerized database.
• Contribute to the completion of complex projects, manage time effectively to meet targets, and develop plans for work activities within a team, while exercising judgment with reliance on supervisor and working under their direction.
• Conduct analytical method validation in accordance with ICH Q2 (R1/R2), USP, and EP standards, encompassing protocol preparation, execution, approval of validation summaries, and coordination with cross‑functional teams.
• Conduct test method GAP assessments against USP, EP, BP, and JP requirements for New Product Introduction (NPI).
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).
• Manage working standards in compliance with established procedures.

Employment details

• Location: India - Vizag

Application details

• Demonstrate knowledge of ICH Q9 (Quality Risk Management) and apply risk‑based principles for identifying, assessing, controlling, communicating, and reviewing quality risks throughout the product lifecycle.
• Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.

About the employer

• Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Additional role details

• Use Your Power for Purpose
• Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients.
• Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance.
• Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care.
• By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
• What You Will Achieve
• Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending appropriate corrective actions.
• Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices and are filed according to existing policies.
• Here Is What You Need (Minimum Requirements)
• Master’s degree in chemistry/ pharmacy with 8-10 years of experience in Analytical Method Transfer / Validation)
• Qualified in multiple analytical techniques ( HPLC-with Empower, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, and pH meters)
• Demonstrated technical skills in method validation and testing
• Ability to read and understand applicable compendial methods, Standard Operating Procedures, technical procedures, and governmental regulations
• Execute and document analytical method verification and method transfer activities.
• Handling of OOS and OOT through QMS.
• Perform identification, assay, purity, and related analytical tests using validated methods.
• Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.
• Handle change control activities and ensure timely implementation and closure of related CAPA actions.
• Excellent organizational skills and strong ability to multi-task
• Strong written and verbal communication skills
• Proficiency with unique Quality Control instruments to meet accuracy specifications for sample management, retains management, interpretation, and evaluation
• Bonus Points If You Have (Preferred Requirements)
• Experience with laboratory work, particularly using analytical HPLC (High Pressure Liquid Chromatography),GC,IC, ICP-MS techniques
• Proven track record in leading continuous improvement projects
• Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis
• Strong problem-solving skills and attention to detail
• Ability to manage multiple priorities and meet deadlines.
• Excellent interpersonal skills and the ability to communicate effectively with colleagues at all levels
• Adaptability and willingness to learn new techniques and procedures
• Work Location Assignment: On Premise
• 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