Associate Manager - Quality Control

Job Description:

Responsibilities

• 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.

Qualification & Experience

• Master’s degree in chemistry/ pharmacy with 5-7 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