QA Executive

Job Summary Responsibilities

• Ensure compliance with cGMP, GLP, SOPs and regulatory requirements.
• Review and approve BMR/BPR, SOPs, specifications and quality documents.
• Handle Deviations, OOS/OOT, CAPA, Change Control and investigations.
• Monitor QA activities across manufacturing and ensure GMP compliance.
• Conduct and support internal, customer and regulatory audits.
• Coordinate validation, qualification and documentation activities.
• Handle market complaints, product recalls and quality investigations.
• Ensure data integrity and Good Documentation Practices (GDP).
• Prepare and review PQR/APQR and quality-related reports.
• Coordinate with Production, QC, Engineering and other departments for quality compliance.
• Support regulatory inspections and ensure timely closure of audit observations.
• Train personnel on GMP, SOPs and quality systems.

Required Skills

• Strong knowledge of Pharma QA QMS
• GMP and regulatory compliance
• Deviation, CAPA Change Control
• Audit and inspection handling
• BMR/BPR and documentation review
• Validation qualification exposure
• Good analytical, communication and coordination skills
• Knowledge of ERP/eQMS will be an added advantage

Required Qualification Key Skills

• Oos/oot
• Capa
• Cgmp
• Glp
• Sops