QA Qualification Officer

About the role

We are looking for a QA Qualification Officer to lead the planning and execution of qualification activities for machines, equipment and services within our pharmaceutical manufacturing site in Semarang. The role ensures that all assets operate according to defined criteria and that product specifications are consistently met.

Key responsibilities

• Plan, schedule and perform qualification studies for new and existing equipment.
• Conduct Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) according to GMP standards.
• Document qualification results and verify compliance with product specifications.
• Collaborate with cross‑functional teams to resolve qualification issues and implement corrective actions.
• Maintain qualification records and ensure they are audit‑ready.

Required profile

• Pharmacy degree (Apt).
• Minimum 3 years experience in a QA department focused on qualification.
• Strong understanding of GMP regulations.
• Ability to work independently and as part of a team.
• Willingness to be based in Semarang.

Required skills

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Good Manufacturing Practice (GMP) knowledge

What we offer

• Competitive salary package.
• Opportunity to work with a leading multinational pharmaceutical group.
• Professional development in a dynamic manufacturing environment.