QA Compliance Officer – Pharmaceutical Division

About the role

The QA Compliance Officer supports the Quality Assurance function in a large pharmaceutical manufacturing plant. Reporting to the Senior Manager Compliance, the role ensures that all processes meet current Good Manufacturing Practice (cGMP) standards, corporate quality policies, and regulatory expectations.

Key responsibilities

• Prepare the site for regulatory inspections, customer audits, internal audits and quality assessments.
• Manage change‑control activities from initiation through closure, ensuring compliance with quality and regulatory requirements.
• Qualify, approve, induct and periodically re‑evaluate suppliers, vendors, contractors and service providers.
• Coordinate supplier audits, vendor assessments and qualification of APIs, raw materials, packaging materials and outsourced services.
• Maintain the Approved Supplier List (ASL) and monitor supplier performance using defined KPIs.
• Track and verify the implementation and effectiveness of CAPA actions arising from audits and inspections.
• Review supplier change notifications, perform impact assessments and update SOPs as needed.
• Support Product Quality Reviews and First Lot Quality Review documentation.

Required profile

• Strong understanding of cGMP, Quality Management Systems and regulatory compliance.
• Experience with supplier qualification, audit coordination and change‑control processes.
• Ability to analyse data, prepare performance reports and maintain controlled quality documentation.
• Excellent attention to detail and ability to work cross‑functionally.

Required skills

• cGMP compliance
• Quality Management System (QMS) knowledge
• CAPA management
• Supplier qualification and audit procedures
• Change‑control processes
• SOP development and maintenance