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Open nowPosted yesterday

QA Compliance Specialist

MyCareersFuture96,520 open roles

Pay
SGD 4,500 – SGD 6,900 a month
Where
Central, Singapore
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Your applicationOpen nowQA Compliance SpecialistMyCareersFuture · Central, Singapore

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The clock on this job

Early applications get read.

8.2% of postings close within 7 days. Measured by our own scanner across the market. MyCareersFuture postings stay open a median of 4 days.

Share of postings closed within
  1. 1.8%1 day
  2. 3.8%3 days
  3. 8.2%7 days
  4. 15.2%14 days
  5. 34.2%30 days
This job: posted yesterday

MyCareersFuture median: 4 days open

The posting

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
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