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- Affiliate: Roche Pharma Korea
- Cluster: Access & Policy
- Work Location: Hanam City, Gyeonggi-do
- Worker Type: 1.5 year contractor
- Your key responsibilities
QC Operations & Testing: Perform QC testing for biological/chemical drug products utilizing compendial methods, ensuring strict adherence to SOPs and test protocols.
Equipment Lifecycle Management: Execute and coordinate qualification, calibration, and preventive maintenance of QC instruments (HPLC, CE, etc.) ensuring intended use.
Data Integrity & Review: Conduct technical review of analytical data (including Audit Trails) to verify compliance with ALCOA+ principles
Method Transfer: Support internal/external analytical method transfer activities, providing technical expertise on key analytical methods.
Investigation & CAPA: Lead or support investigations for OOS/OOT results and deviations, identifying root causes and implementing effective CAPAs.
Documentation: Draft and revise QC SOPs, protocols, and reports, ensuring Good Documentation Practices (GDP) are maintained.
Regulatory Collaboration: Collaborate with RA to establish specifications and test methods for drug product registration.
-Who you are
Basic qualification: Bachelor of Science majoring 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.
Submission
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A healthier future drives us to innovate. Together, more than 100â000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.
Letâs build a healthier future, together.
Roche is an Equal Opportunity Employer.

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.
Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.
Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. Thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Roche has been recognised as the Group Leader in sustainability within the Pharmaceuticals, Biotechnology & Life Sciences Industry ten years in a row by the Dow Jones Sustainability Indices (DJSI).
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