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., aiming to improve competitiveness in the global PDMP market. SK Plasma is building a plasma fractionation plant in order to improve the self-sufficiency of PDMP in Indonesia through a joint venture with capable business partners under the support of the Indonesian government.
Role Description :
1) Establishment and operation of Quality Management System(QMS)
- Preparation of Standard Operating Procedure(SOP) including product specification, Batch record, registration documents
- Document control
- Change control/Deviation management/CAPA management
2) Training management
- Training planning and sheduling
- Training record management
3) Supplier evaulation
Required :
- Minimum Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Biology, Biotechnology, Microbiology, Chemistry, Chemical Engineering or any related fields.
- 3 - 5 years experienced in the establishment/operation of QMS and GMP compliance in the Pharmaceutical Industry
- Proficiency in English (both written and spoken)
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)
- Proficiency in Korean