QA & Regulatory Compliance Lead

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

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.