Job Description :
- Create manuals and work programs for the Compliance & Regulatory department (excluding OHS and environmental aspects) and maintain documents related to the company's management systems.
- Ensure the implementation of management systems and applicable regulations across the Company's areas.
- Socialize policies and implementation provisions of management system programs within the Company.
- Conduct periodic reporting to relevant government agencies such as BPOM, Dinkes (Health Office), BPJPH, LPPOM MUI, etc., as well as to relevant certification bodies.
- Ensure and lead the execution of internal, external, and customer audits within the company.
- Prepare reports and documentation of internal, external, and customer audit activities for relevant stakeholders.
- Develop continuous corrective action plans to prevent recurrence of issues and create better conditions in the future.
- Conduct recall and traceability simulations on a periodic basis.
- Conduct supplier assessment and evaluation.
- Establish the supply chain. 11. Provide training related to the management systems implemented by the company, including CDOB, CDOIB, ISO, Halal, NKV, and others.
Requirements :
- Minimum Bachelor's degree (S1) – Pharmacist / Pharmacy.
- Minimum 3 years of experience in regulatory affairs handling CDOB, CPOB, and CPKB (experience in NKV and ISO 9001 management would be an advantage).
- Good communication skills, able to work in a team, and analytical thinking.
- Holds an active SIPA and STRA that are currently not in use (available).
- Understands regulations related to CDOB, CPOB, CPKB, NKV, and ISO 9001. 6. Willing to be placed/based in South Tangerang.