Quality Assurance & Regulatory Affair

Tanggung jawab

• Organizing QA & RA documentation systematically to facilitate easy identification of products and regulatory information.
• Controlling labeling, storage, and distribution processes in compliance with quality standards (GMP) and applicable regulations.
• Ensuring product and document compliance with the requirements of health authorities (e.g., BPOM).
• Preparing and reviewing product registration documents for regulatory submissions and audits.
• Coordinating with cross-functional teams to ensure the implementation of quality and regulatory standards throughout the product lifecycle.

Persyaratan

• Min. Bachelor's Degree in Pharmacy (Profesi Apoteker)
• Min. one year of experience as a Pharmacist-in-Charge at a PBF
• Have active SIPA and STRK
• Have knowledge about CDOB, CDAKB, SMKPO, ISO
• Have knowledge about Validation, Quality management system (change control, Deviation, CAPA, QRM)
• Able to operate Ms. Office for standard use
• Placement for Enseval's Subsidiaries: Emos Global Digital