QA Operations Lead: Batch Release & Compliance

Menarini Asia-Pacific

Desa Ciranjeng

On-site

IDR 240,000,000 - 360,000,000

Full time

35 hours ago
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Job summary

Menarini Asia-Pacific is seeking a QA Operation Supervisor in Indonesia to oversee batch release activities, review batch records, and ensure regulatory alignment. The role leads IPC oversight, deviation investigations, and end-to-end handling of customer complaint resolution with proper documentation.

You will collaborate across functions, apply GMP and GDP principles, guide validation and CAPA processes, and ensure continuous quality improvement in a fast-paced pharmaceutical environment.

Qualifications

  • Pharmacist degree required with supervisory experience in QA.
  • Strong knowledge of GMP and GDP principles.
  • Experience with CAPA, deviation investigations, and regulatory compliance.
  • Excellent ability to interface with cross-functional teams and customers.

Responsibilities

  • Oversee batch release activities and ensure regulatory compliance.
  • Supervise In-Process Control (IPC) activities and GDP adherence.
  • Lead root-cause investigations for non-conformances and track corrective actions.
  • Manage customer complaints investigations and controlled document lifecycle.

Skills

Analytical thinking
Investigation
Problem solving
Interpersonal skills
Communication skills

Education

Pharmacist degree

Job description

Menarini Asia-Pacific is seeking a QA Operation Supervisor in Indonesia to oversee batch release activities, review batch records, and ensure regulatory alignment. The role leads IPC oversight, deviation investigations, and end-to-end handling of customer complaint resolution with proper documentation.

You will collaborate across functions, apply GMP and GDP principles, guide validation and CAPA processes, and ensure continuous quality improvement in a fast-paced pharmaceutical environment.

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