Roche is looking to solve the problem of ensuring everyone has access to the healthcare they need today and for generations to come by driving and realizing cell and gene therapies
Requirements
- You have robust experience performing QA oversight in a GMP environment.
- You have advanced GMP process and equipment experience and knowledge of requirements related to biologic drug substance manufacturing.
- You have in-depth knowledge of global regulations including 21 CFR Part 11, 210 and 211, Eudralex Volume 4, Part IV, relevant USP and ICH guidelines and Data Integrity requirements.
- You have experience in rAAV Gene Therapy manufacturing.
- You have performed in a QA role (or similar) during startup and qualification of a new GMP manufacturing facility.
- You are well known for your motivation as well as your independent, yet collaborative working style.
- You have knowledge of computerized systems.
Responsibilities
- You will support the QA oversight for qualification and startup activities for large capital projects.
- You will ensure compliance with the Quality Management System by representing QA in the facilitation and closure of Change Controls, Deviations, investigations, CAPAs and Risk Assessments.
- You will review and approve system lifecycle documentation for GMP equipment, facilities, utilities, and analytical instruments.
- You will take a lead role driving continuous process improvements and lead individual quality initiatives.
- You will provide oversight and guidance to project-based Quality Assurance contractors.
- You will ensure compliance with the Quality Management System by representing QA in the facilitation and closure of Change Controls, Deviations, investigations, CAPAs and Risk Assessments.
- You will support the implementation and lifecycle management of GMP manufacturing processes, equipment, facilities, utilities and computerized systems.
Other
- You hold a Bachelor's degree in Biology, Chemistry, Engineering or related life sciences and generally 5-12+ years of experience in the Pharmaceutical/Biotechnology industry
- You are characterized by a high level of social competence, a competent independent decision maker and are able to accurately record and efficiently communicate in English.
- Relocation benefits are not available for this posting
- A discretionary annual bonus may be available based on individual and Company performance.
- This position also qualifies for the benefits detailed at the link provided below.
