한국로슈 QC Partner Contractor 계약직 채용

Cluster: A&P Cluster/QC Chapter

Worker Sub-Type: Temporary (1 Year)

Work Location: Hanam City, Gyeonggi-do

Your key responsibilities

• Management of QC equipment qualification, calibration, and preventive maintenance

• QC testing for biological/chemical drug products (focused on Compendia type methods, 바이오의약품 제품 시험)

• Both internal and external analytical method transfer exercise as a SME

• Technical review of QC raw data

• Various QC SOPs, work instructions, protocols, and report generation/revision (as necessary)

• Handling of deviation, OOS investigation, change control, CAPA, and risk assessment, etc.

• Adhere to the current GxP good documentation practices and data integrity requirements

• Management of QC material: QC sample/Retention sample, critical reagents, & cell banking

• A member of local QMR Meeting (Quality Management Review Meeting)

• Collaboration work with RA: Preparation of specification and test method for drug product

Who you are

• Basic qualification: Bachelor of Science majored in biotechnology or related science

• A minimum of 3 years experience in developing and executing quality control operation, and laboratory experience in pharmaceutical company

• A strong background and in depth knowledge in Instrumental analysis (HPLC, UV, CE, Spectrophotometer, Plate Reader, etc.)

• Good English written and communication skill