Quality Compliance & Audit Management (1-year fixed term contract)

PURPOSE

As the Subject Matter Expert (SME) and coordinator of the Compliance Management System (CMS) implementation, I oversee the local regulation review, compendial updates, internal and external audit plan management, and execution. I coordinate food safety compliance and the Halal Assurance System (HAS), as well as prepare and implement authority audits (BPOM, TGA, etc.) for re-certification or new certification. Additionally, I manage Corrective and Preventative Actions (CAPA) from audit observations to ensure timely closure, while also ensuring compliance with mandatory authority reporting and the completion of relevant mandatory training. This role also includes responsibility for master data management for SAP QM in handling the inspection plans for materials, finished goods, and stability.

KEY TASKS

• Support the coordination of site compliance with certification requirements related to operational activities.
• Perform compliance assessment reports and assign responsible individuals (PIC) for the CMS and local regulation implementation, including compendial updates, to ensure compliance with additional duties and national requirements at Bayer Cimanggis.
• Ensure that Corrective and Preventative Actions (CAPAs) generated from audit observations are verified for effectiveness as supporting audit evidence, where applicable, and that such audits are documented.
• Create and/or review procedures (e.g., SOPs and templates) related to compliance and audit management to ensure alignment with updated requirements (e.g., CMS Bayer Regulation: GOI, GSOP, Supplement, Best Practices; Local regulations: CPOB, HALAL, SMK3; International guidelines: PICs; Compendial: Pharmacopoeia).
• Coordinate and maintain the annual supplier audit plan, including preparing the audit agenda with cross-functional groups, conducting audits, managing audit reports, following up on the status of corrective actions, and closing audits.
• Support the Global Audit Committee/Global Assigned Auditors by providing information for audit preparation.
• Assist in the implementation of the Audit Management System for audit planning, execution, reporting, and closure.
• Responsible for master data management for SAP QM in handling inspection plans for materials, finished goods, and stability.
• Follow up on CAPA recommendations from events, deviations, and risk assessments in the iQMS system, ensuring that action tasks assigned from the change management system are closed in a timely manner.

SKILLS & REQUIREMENTS

• Pharmacist with a minimum of 1 year of experience in GMP aspects and Quality Assurance.
• Familiarity with international and local GMP principles for the manufacturing of pharmaceutical products and food supplements.
• A team player who can also work independently and deliver results with minimal guidance.
• Attention to detail and a focus on the quality of work.
• Proficient English skills and the ability to work within an international team.
• Strong problem-solving abilities.
• Good organizational and time management skills.
• Proven flexibility and adaptability.