Associate Manager Quality Control in Visakhapatnam, भारत
Pfizer
Visakhapatnam, भारत
Pfizer seeks an Associate Manager in Quality Control for its Vizag facility to lead analytical method validation, testing, and compliance activities. The role involves managing complex analytical techniques, ensuring cGMP adherence, and supporting product quality across development and manufacturing operations.
Responsibilities
Execute method transfers, validations, and verifications for complex analytical techniques
Interpret analytical data for accuracy and precision; recommend corrective actions based on cGMP impact
Conduct testing on finished products, raw materials, and components; manage data entry and approval in computerized systems
Review and update standard operating procedures, analytical methods, and technical documentation to maintain compliance
Lead continuous improvement initiatives and support process validation and troubleshooting with cross-functional teams
Requirements
Master's degree in chemistry or pharmacy with 8-10 years of analytical method transfer or validation experience
Proficiency in multiple analytical techniques including HPLC, GC, IC, ICP-MS, potentiometry, UV-Vis, FTIR, Karl Fischer titration
Knowledge of ICH Q2 (R1/R2), USP, EP, BP, and JP compendial standards and validation protocols
Understanding of ICH Q9 quality risk management principles and their application to product lifecycle
Strong written and verbal communication skills with excellent organizational and multitasking abilities
Experience handling out-of-specification and out-of-trend results through quality management systems
Familiarity with GMP, GLPs, change control, and CAPA processes
Pfizer seeks an Associate Manager in quality assurance for its Vizag facility to lead analytical method transfers, validations, and verifications. The role involves interpreting analytical data, ensuring GMP/GLP compliance, and supporting product quality through complex testing and process validation activities. Responsibilities ...
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