Primary Responsibility
Develop, implement, perform and maintain company’s quality systems and procedures for the QA, CMC, RA and related development departments
Review cGMP documentation, including, but not limited to master and executed batch records related to drug product, drug substance manufacture, etc.
Support cross functional audits and activities as required
Ensure timely routing and processing of all documents
Qualification
Qualification
- License: Pharmacist.
- More than 10 years Job Experience. Need to have experience like below
Good English speaking and writing skill
Good GMP Documentation skill (Site master file, Policy, SOP etc.)
QA of Sterile product as assistant manager or supervisor
Validation Knowledge and experience for sterile production. (VMP, IQ/OQ & PQ and Process validation, Media fill Test)
Managing GMP Inspection from BPOM, WHO, EMEA or Foreign global pharmaceutical company.
Good Knowledge for GMP regulation Like BPOM, cGMP, EMEA GMP.
Construction for New Pharmaceutical Plant
Leadership on Pharmaceutical QA area
Informasi lebih lanjut
Bidang Pekerjaan |
Status Kepegawaian |
Pabrik/Manufaktur/Bagian Produksi
|
Full-Time
|
Pendidikan Terakhir |
Gaji |
Sarjana/S1
|
Sesuai Peraturan Perusahaan
|
Tingkat Jabatan |
|
Manager
|
-
|
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