Senior Executive – Quality Assurance

Job Description

We are hiring a Senior Executive – Quality Assurance for a pharma formulation unit.

The candidate will be responsible for QA systems, compliance, and validation activities.

Key Responsibilities

• Perform risk assessment and implement QA controls.
• Handle qualification and validation activities (equipment, process, cleaning).
• Ensure compliance with Schedule M, WHO-GMP, and EU-GMP guidelines.
• Prepare and review QA documentation including SOPs, BMR/BPR, and reports.
• Conduct internal audits and support external audits.
• Handle deviations, CAPA, and change control processes.
• Monitor compliance and quality systems across production.
• Coordinate with cross-functional teams for QA activities.
• Maintain documentation and regulatory compliance.

Required Skills

• Strong experience in pharma formulation QA.
• Knowledge of Schedule M (ICR), WHO-GMP, and EU-GMP.
• Experience in validation and qualification processes.
• Good understanding of risk assessment and CAPA.
• Strong documentation and audit handling skills.
• Attention to detail and regulatory compliance mindset.
• Good communication and coordination skills.