Associate Manager

Pfizer Inc.; India; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Pfizer Vizag is seeking an Associate Manager for analytical method transfer and validation. In this role you will lead method transfers, validations, and verifications across complex analytical techniques, ensure cGMP/GLP compliance, and maintain documentation and SOPs.

You will review data for accuracy, coordinate with QC, Production, and QA, and support continuous improvement projects while developing team plans.

Qualifications

• Master’s in chemistry or pharmacy with 8–10 years in analytical method transfer/validation.
• Experience with multiple analytical techniques and regulatory standards.
• Ability to read compendial methods and regulatory documents.
• Experience with ICH Q2, USP, and EP standards.
• Strong written and verbal communication skills.

Responsibilities

• Perform method transfers, validations, and verifications for complex analyses.
• Review SOPs and update methods and documents.
• Evaluate data for accuracy and trends; document results.
• Coordinate with cross-functional teams and support CAPA.
• Ensure compliance with cGMP and GLP in documentation.

Skills

Analytical method validation

cGMP knowledge

Cross-functional collaboration

Documentation & SOP writing

Problem solving

Education

Master’s degree in Chemistry or Pharmacy

Tools

HPLC with Empower

GC

IC

ICP-MS

Potentiometry

UV-Vis

FTIR

Karl Fischer

pH meters

Job description

Associate Manager### Associate ManagerBewerben: India - Vizag: Vollzeit: Heute ausgeschrieben: 4966809**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.* 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 proceduresWork Location Assignment: On Premise 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