QUALITY ASSURANCE SUPERVISOR

PT Bahtera Adi Jaya; Tangerang Selatan; On-site; IDR 250,000,000 - 420,000,000; Full time

Job summary

PT Bahtera Adi Jaya is seeking a Regulatory Affairs professional to oversee CDOB, CPOB, and CPKB compliance, with at least 3 years in regulatory affairs and SIPA/STRA active status. The role requires a pharmacist with strong analytical skills and teamwork in a South Tangerang base.

The person will develop manuals, socialize management systems, and lead audits across internal, external, and customer interfaces while maintaining documentation for regulatory bodies and certification programs.

Qualifications

• Bachelor's degree in Pharmacy is required.
• Minimum 3 years of regulatory affairs experience handling CDOB, CPOB, and CPKB.
• Familiarity with NKV and ISO 9001 is a plus.
• Active SIPA and STRA certificates; available but not currently in use.
• Willingness to be based in South Tangerang; able to work in a team.

Responsibilities

• Create manuals and work programs for Compliance & Regulatory department.
• Ensure implementation of management systems and regulations across locations.
• Socialize policies and ensure program adoption company-wide.
• Lead internal, external, and customer audits and prepare audit reports.
• Develop corrective action plans to prevent recurrence of issues.
• Conduct recall and traceability simulations periodically.
• Perform supplier assessments and establish supply chain processes.
• Provide training on management systems (CDOB, CDOIB, ISO, Halal, NKV).

Skills

Regulatory affairs

Audit coordination

Analytical thinking

Communication

Education

Bachelor's degree in Pharmacy

Tools

SIPA & STRA licenses

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.