Quality Assurance Sr. Officer

Key Responsibilities

• Handle and coordinate Change Control activities, including impact assessment, implementation, and closure.
• Prepare, review, and control SOPs, specifications, formats, and other GMP documents.
• Manage SOP revisions and ensure timely review, approval, implementation, and training.
• Support and review Equipment Qualification activities such as DQ, IQ, OQ, and PQ.
• Handle Deviation investigations, assessment, documentation, and closure.
• Coordinate and review Process Validation protocols and reports, including validation planning, execution, data review, deviation assessment, and final report approval.
• Handle Cleaning Validation activities, including preparation/review of protocols and reports, sampling plans, acceptance criteria, swab/rinse sampling, recovery studies, and evaluation of analytical results.
• Coordinate CAPA identification, implementation, effectiveness checks, and closure.
• Perform/support Root Cause Analysis (RCA) using appropriate investigation tools such as 5-Why and Fishbone Analysis.
• Review BPR/BMR (Batch Production/Manufacturing Records) for completeness, compliance, and adherence to approved procedures.
• Ensure proper review of manufacturing and packing documentation before batch release/approval as applicable.
• Monitor compliance with GMP, SOPs, data integrity, and quality systems.
• Coordinate with Production, QC, Engineering, Warehouse, and other departments for investigation and quality-related activities.
• Support investigation of process/product-related quality issues and implementation of corrective and preventive actions.
• Maintain QA documentation and ensure timely closure of assigned quality-system activities.
• Provide QA support for API manufacturing processes and demonstrate good understanding of manufacturing operations and process controls.