QA Compliance Specialist

Our client, a leading biopharmaceutical manufacturer, is looking for a QA Compliance Specialist to join their Site Compliance team in Singapore. You'll help keep the site inspection-ready, champion data integrity and support internal audits and external regulatory inspections. This role suits a people-oriented QA professional who enjoys working with different teams and wants hands-on exposure to audits and inspections in a GMP environment.

Key Responsibilities

Data Integrity

• Deliver data integrity training to new employees as part of onboarding, and run the yearly site-wide refresher.
• Review data integrity documents, including audit trail reviews and data integrity risk assessments (DIRA).
• Promote good data governance practices across the site.

Internal Audits

• Co-audit internal audits as part of the site's yearly audit programme.
• Support CAPA follow-ups, response discussions and tracking so that audit actions are closed properly and on time.

Inspection Readiness & External Inspections

• Act as Compliance Partner to an assigned department, working with subject matter experts on inspection rehearsals and storyboard preparation.
• Support external regulatory inspections from preparation to execution, including logistics, training of back-room support staff and coordinating documents.

Compliance Support

• Track and monitor open compliance tasks.
• Support the revision and routing of documents in the electronic document management system.

Requirements

• Hands-on Quality Assurance experience in GMP manufacturing operations.
• Experience in QA Operations or Compliance is preferred. General QA experience in API or biologics manufacturing will also be considered.
• Experience supporting internal audits or external regulatory inspections is an advantage.
• Good understanding of data governance and data integrity principles (e.g. ALCOA+).
• Confident delivering instructor-led training to new hires and to site-wide audiences.
• Knowledge of engineering operations and OT/IT systems (e.g. DeltaV) is an advantage.
• Strong communication and technical writing skills.
• Strong compliance mindset, adaptable and a team player who is comfortable with a wide range of tasks.
• Able to work extended hours during planned external inspections