Roche is looking to innovate and advance science to ensure everyone has access to the healthcare they need, and this role is critical in supporting the Quality Product Review and Release (QPR&R) team to provide world-class biological products for patients, directly impacting product quality and patient safety.
Requirements
- You have knowledge of manufacturing data, QC data, computerized systems, laboratory testing and test methods, GMP records.
- Understanding biological clinical product development process, especially about the analytical method development, validation, and testing, is strongly preferred
- Experience with Veeva (QMS), S4/HANA P1S SAP, BRH, Single LIMS, GLAS/MDMS
Responsibilities
- You perform thorough evaluations of raw materials and in-process items for the timely and accurate release of these materials for production based on established quality standards and test results.
- You conduct comprehensive reviews of assay histories to confirm all test results are accurate and complete.
- You are making informed and independent decisions on complex issues in collaboration with key stakeholders and alignment with Roche/Genentech policies.
- You lead or participate on interdepartmental/global teams, process improvements, and new process design.
- The role is a critical member of the Quality Product Review and Release (QPR&R) team.
- The QPR&R team spans synchronous DP production floor oversight including recipe & ticket approvals, incoming and direct material releases, assay history review and CoA generation, product release, and Quality Single Point of Contact (QSPOC) for products ranging from early NMEs through PhIII and commercial products in new indication trials.
Other
- You hold Bachelor’s degree in Life Sciences, Engineering, or a related field.
- You have 5+ years of experience in the pharmaceutical industry.
- You have a proven ability to successfully collaborate on site initiatives while managing daily responsibilities and meeting deadlines.
- Relocation benefits are not available for this posting
- Genentech is an equal opportunity employer.
