QA Officer / Quality Assurance Executive

About the role

The Quality Assurance Officer will support the QA Manager in maintaining ISO 9001:2015 compliance and Good Distribution Practice (GDP) across pharmaceutical, medical device, and laboratory product distribution. This role ensures that all quality systems, documentation, and regulatory requirements are consistently applied.

Key responsibilities

• Maintain and implement ISO 9001:2015 QMS requirements.
• Support GDP compliance for warehouse and distribution activities.
• Control SOPs, policies, forms, records, and the Master Document List.
• Manage deviations, CAPA, change controls, and risk assessments.
• Conduct internal audits and assist with supplier/customer audits.
• Monitor temperature‑controlled storage and transportation records, review excursions, and prepare reports.
• Maintain training records and the training matrix.
• Support supplier qualification, periodic evaluation, and product complaint handling.
• Ensure calibration and qualification records are up to date.
• Follow up on audit findings and verify CAPA effectiveness.
• Prepare QA reports and inputs for management review.
• Coordinate quality requirements with third‑party service providers.

Required profile

• 2–5 years of experience in pharmaceutical, medical device, laboratory, or healthcare distribution.
• Training or qualification in ISO 9001, GDP and/or GMP is highly desirable.
• Strong understanding of GDP principles and QMS documentation.

Required skills

• ISO 9001:2015 implementation
• Good Distribution Practice (GDP)
• Good Manufacturing Practice (GMP) awareness
• Internal auditing
• CAPA and deviation management
• Risk assessment
• Temperature‑controlled product handling
• QMS documentation and SOP preparation
• Supplier qualification and evaluation
• Calibration and qualification record maintenance