QA TEAM (QMS & GMP COMPLIANCE)
Persyaratan
Tunjangan dan keuntungan
Makanan & minuman gratis
Avoid wasting time and energy to buy food at the restaurant or hawker center by yourself. We'll provide the best food for you and your team. Make better use of your valuable time to rest, bond, and do other things that matter to you.
Perjalanan gratis
We understand that commuting for work costs you money, time, and energy. For that reason, we can provide you with travel accommodations and allowances so you can focus on what's important. No need to worry about travel expenses.
Kesehatan
As much as we care about our business, we also care for every one of our employees' wellness. To keep you happy at work, we provide a range of self-help services and facilities that you can use at any moment.
Liburan & Cuti
Feel a need for a short break from work? our company is quite flexible when it comes to leaves; be it for vacation, sick, personal, or mental health days. Simply discuss what you need and we will try to cater to those.
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Skills
Deskripsi pekerjaan QA TEAM (QMS & GMP COMPLIANCE) PT SKPLASMA CORE INDONESIA
Role Description :
- Technology transfer (Preparation of documentation for technology transfer, Preparation of Standard Operating Procedure(SOP) including product specification, Batch Record, Registration documents)
- Establishment and operation of Quality Management System/QMS (Change control/Deviation management/CAPA management, Contamination Control Strategy (CCS), Document control)
- Supplier evaluation
Qualifications :
Required :
- Minimum Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering or any related fields
- More than 5 years experienced in the establishment/operation of QMS and GMP compliance in the Pharmaceutical Industry
- Fluent in English is a must
Preferably :
- Experienced in QA Department in the Biopharmaceutical Industry
- Experienced in the initial setup and operation of QMS in a newly constructed Biopharmaceutical Facility
- Experienced in the establishment and management of CCS
- Experienced in technology transfer process
- Having Pharmacist Licence (Surat Tanda Registrasi Apoteker)
- Fluent in Korean is a plus point
SK Plasma has grown steadily on the foundation of PDMP (plasma-derived medicinal products) business starting from 1970. In 2015, SK Plasma resolved to build a state-of-the-art plasma fractionation plant and has spun off from SK Chemicals Life Science biz.
Gedung Office 8, Level 18-A, jalan Senopati No. 8B, Kawasan SCBD, Desa/Kelurahan Senayan, Kec. Kebayoran Baru, Kota Adm. Jakarta Selatan, Provinsi DKI Jakarta. Kode Pos: 12190
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