QC Partner

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.

The Position

Your key responsibilities

• Advanced QC Testing: Perform QC testing for biological/chemical drug products utilizing various compendial and in-house validated methods (e.g., ID/Purity by CE, HPLC & UPLC, Content by UV/Vis, Cell-based Assays), ensuring strict adherence to SOPs and test protocols.
• QC Material & Cell Bank Management: Manage and maintain critical QC materials including QC/retention samples, critical reagents, and cell banking.
• Method Transfer (SME): Lead or support internal/external analytical method transfer activities, providing technical expertise on key analytical methods as a Subject Matter Expert.
• Investigation & Quality Management: Handling of deviations, OOS/OOT investigations, change controls, CAPA, and risk assessments, identifying root causes and implementing effective actions.
• Audit & QMR Leadership: Act as an internal or external GxP auditor/co-auditor and represent the QC function as a member of the local QMR (Quality Management Review) Meeting.
• Data Integrity & Review: Conduct technical review of QC raw data and analytical results, adhering strictly to the current GxP good documentation practices and data integrity requirements.
• Equipment Lifecycle Management: Execute and coordinate qualification, calibration, and preventive maintenance of QC equipment ensuring intended use.
• Documentation & Regulatory Collaboration: Draft, review, and revise various QC SOPs, work instructions, protocols, and reports. Collaborate closely with RA for the preparation of 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 4 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.) and cell-based assays.
• Good English written and communication skill.

Who we are

A healthier future drives us to innovate. Together, more than 100’000 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.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.