QA Officer

Job Summary Responsibilities

• Ensure compliance with cGMP, GLP, and regulatory requirements.
• Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), and analytical reports.
• Handle deviations, change controls, CAPA, OOS, OOT, and risk assessments.
• Conduct line clearance, in-process checks, and shop floor monitoring.
• Review and maintain SOPs, specifications, protocols, and quality documents.
• Coordinate qualification and validation activities (IQ/OQ/PQ, Process Validation, Cleaning Validation).
• Perform internal audits and support regulatory/customer audits.
• Monitor compliance with data integrity and documentation practices.
• Ensure timely closure of quality-related observations and investigations.
• Support product release activities and maintain QA records.

Required Skills

• Knowledge of GMP, GLP, ICH, WHO, and regulatory guidelines.
• Experience in documentation review and QMS activities.
• Good understanding of validation, qualification, and audit compliance.
• Strong analytical, communication, and problem-solving skills.

Required Qualification Key Skills

• Qa
• Officer