Quality Management System (QMS)

• Ensure compliance with GDP regulations and internal standards.
• Develop and manage SOPs, policies, and records.
• Support other teams with procedures and controls.
• Report quality trends and KPIs to senior leadership.

Handling Quality Events

• Oversee customer complaints, deviations, recalls, and product returns.
• Coordinate investigations and implement corrective actions (CAPAs).
• Maintain accurate records of all quality-related events.

Training

• Deliver GDP training to internal teams and partners.
• Manage training records and qualifications documentation.

Audits & Inspections

• Plan and conduct internal and external audits.
• Host regulatory inspections (e.g. SUKL, IGJ).
• Respond to audit findings and oversee follow-ups.

Supplier & Partner Oversight

• Manage QA Agreements with suppliers and distributors.
• Approve and monitor partners for compliance.
• Check licenses to ensure legal product distribution.