QA Operation Supervisor

Menarini Asia-Pacific; Desa Ciranjeng; On-site; IDR 240,000,000 - 360,000,000; Full time

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

The QA Operation Supervisor is responsible for overseeing batch release activities, evaluating product quality compliance, and ensuring full alignment with regulatory standards. This role leads batch documentation reviews, oversees In-Process Controls, investigates deviations and non-conformances, and manages the end-to-end customer complaint resolution process.

Key Responsibilities

• Batch Release & Compliance: Review batch records, SOPs, and validation documentation (deviation reports, CAPA, change controls) to guarantee full regulatory compliance before authorizing product release.
• In-Process Control (IPC) Oversight: Supervise daily IPC activities to ensure strict adherence to Good Documentation Practice (GDP) standards and offer technical guidance.
• Deviation & CAPA Resolution: Lead root cause investigations for non-conformances, implement effective corrective actions, and track their long-term effectiveness alongside cross-functional teams.
• Customer Complaints & Document Lifecycle: Handle customer complaint investigations, sample retrievals, and tracking reports while maintaining proper formatting and issuance of controlled document formats.

Requirements

• Pharmacist with minimum 3 years supervisory experience in pharmaceutical or healthcare Quality Assurance.
• Deep working knowledge of Good Manufacturing Practice (GMP), Good Documentation Practice (GDP), CAPA processes, root cause analysis methodologies, and regulatory compliance requirements.
• Strong analytical thinking, investigation, and problem-solving skills.
• Excellent interpersonal and communication skills to effectively interface with cross-functional teams, stakeholders, and customers.