Quality Assurance & Regulatory Affair

PT.Enseval Putera Megatrading Tbk; Jakarta Timur; On-site; IDR 89,280,000 - 133,920,000; Full time

Job summary

PT.Enseval Putera Megatrading Tbk mencari Pharmacist-in-Charge untuk mengelola QA/RA serta memastikan kepatuhan produk terhadap BPOM. Posisi berada di Jakarta Timur dengan pemantauan dokumentasi registrasi, pelabelan, penyimpanan, dan distribusi sesuai GMP dan regulasi terkait.

Anda akan berkoordinasi dengan tim lintas fungsi untuk penerapan standar kualitas sepanjang siklus produk. Persyaratan mencakup SIPA dan STRK aktif, pengalaman minimal satu tahun sebagai Pharmacist-in-Charge di PBF, serta

Qualifications

• Gelar Sarjana Farmasi (Profesi Apoteker) diperlukan.
• N/A

Responsibilities

• mengatur dokumentasi QA & RA secara terstruktur untuk identifikasi produk dan informasi regulatori.

Skills

Quality management knowledge

Validation understanding

CAPA & QRM

Education

Bachelor's Degree in Pharmacy (Profesi Apoteker)

Tools

MS Office

SIPA

STRK

CDOB

CDAKB

SMKPO

ISO

Job description

• 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.

• 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
• Placementin:Jakarta Timur