QA TEAM (QUALIFICATION)

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 planning to build 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 :

A. Qualification :

• DP production equipment (Aseptic Filling machine, Lyophilyzer, etc.)
• Utility equipment (HVAC, PW/WFI, CA, PS, etc.)

B. Validation :

• Batch validation, Validation of contaminant inspection, Media contamination test
• CSV (computer system validation)

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 Qualification and Validation within the Pharmaceutical Industry
• Fluent in English is a must
• Required to have training in Korea for 8 months

Preferably :

• Experienced in Qualification and Validation within the Biopharmaceutical Industry
• Experienced in the initial setup and operation of QA in a newly constructed Biopharmaceutical Facility
• Fluent in Korean is a plus point