Assistant Manager - Quality Assurance, Chemistry

Role Overview: As an Assistant Manager - Quality Assurance in Chemistry, your role will involve managing and controlling various aspects of quality management and continuous improvement in the API industry. You will be responsible for implementing and maintaining quality systems at the site, conducting investigations, reviewing documentation, ensuring compliance with regulatory requirements, and coordinating various activities within the organization. Key Responsibilities: - Management and control of SOPs, Master documents, labels & other GMP impacted documents - Implementing necessary quality systems including complaint investigation, qualification and validation, change control, deviation and non-compliance management, documentation, and supplier quality assurance - Conducting out of specification & out of trend investigations, deviation investigations, and incidence investigations - Reviewing Batch Manufacturing Records (BMRs), Analytical record & related documentation - Validation & qualification activities - Reviewing and managing change controls - Preparing the Annual Product Review and Annual Quality Review - Approving batch rework/reprocessing, repacking, relabeling, and non-standard batch size procedures - Releasing/rejecting API & Intermediate - Conducting training programs - Reviewing stability programs, analytical method validation, and qualification documents - Issuing all related GMP documents - Ensuring adherence to Corporate Quality Directives and Local FDA regulations - Performing gap analysis and developing compliance plans - Supporting Regulatory Affairs in documentation - Preparing for and attending external/regulatory quality audits - Reviewing calibration and preventive maintenance programs - Conducting GMP rounds in the plant - Coordinating with various departments for quality assurance activities - Identifying and correcting unsafe conditions or behaviors - Conducting third party audits as required - Executing any special tasks allocated by Manager Qualifications Required: - M. Sc. Industrial Chemistry / B. Pharma / M. Pharma - 8 to 10 years of experience in the API industry with related experience in QA, Manufacturing & GMP - Knowledge of GMP and regulatory requirements - Good interpersonal, team working, and conflict management skills - Ability to handle complex situations with regulatory compliance - Excellent communication skills - Understanding of global organization and related processes (Note: Additional details about the company were not provided in the Job Description),