Associate Manager Quality Control

Pfizer; Visakhapatnam; On-site; INR 900,000 - 1,200,000; Full time

Job summary

Pfizer Vizag is seeking an Associate Manager Quality Control to lead analytical method transfer and validation activities. You will interpret complex data, ensure GMP/GLP compliance, and supervise documentation processes within a risk-based quality framework.

Responsibilities include reviewing SOPs, performing analyses on raw materials and finished products, coordinating with cross-functional teams, and managing OOS/OOT events through QMS.

Qualifications

• Master’s degree in chemistry/pharmacy with 8–10 years’ experience in Analytical Method Transfer/Validation.
• Proficient in multiple analytical techniques including HPLC, GC, IC, ICP-MS, UV‑Vis, FTIR, and Karl Fischer.
• Ability to read compendial methods and ICH/USP/EP standards; strong documentation practices.
• Experience with QMS, CAPA, change control, and risk-based quality management.

Responsibilities

• Perform method transfers, validations, and verifications to complex analytical techniques.
• Review SOPs and methods; ensure compliance with cGMP and cGLP requirements.
• Conduct analyses on finished products and raw materials; document in the LIMS/QMS.
• Coordinate with cross-functional teams for NPI and process validation activities.
• Handle OOS/OOT events via QMS; support CAPA and change control closures.

Skills

Method transfer

Validation

Data interpretation

Documentation & GMP/GLP

Communication skills

Quality risk management

Leadership

Education

Master’s degree in chemistry/pharmacy

Tools

Analytical instrument proficiency: HPLC, GC, IC, ICP-MS, Potentiometry, UV‑Vis, FTIR, Karl Fischer, pH meters

Job description

## Associate Manager Quality ControlApply: India - Vizag: Full time: Posted Today: 4964676**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**In this role, you will:* Perform method transfers/ validations / method verifications to the complex analytical techniques* 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.* 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.**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* 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).* Execute and document analytical method verification and method transfer activities.* 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.* Handling of OOS and OOT through QMS.* Perform identification, assay, purity, and related analytical tests using validated methods.* Monitor critical process parameters (CPPs) and critical quality attributes (CQAs).* Support process validation and troubleshooting activities; communicate analytical results promptly to Production and QA to ensure effective process control.* Manage working standards in compliance with established procedures.* Handle change control activities and ensure timely implementation and closure of related CAPA actions.* Knowledge of Good Manufacturing Practices and its application standards, processes, and policies.* 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