About the Company:
Our client is a biopharmaceutical company engaged in the development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care. The company is focused on chimeric antigen receptor (CAR) and T cell receptor (TCR) engineered cell therapies designed to empower the immune system's ability to recognize and kill tumors.
Our client is currently adding additional talent as it focuses on developing the European Region in support of providing maximum access to patients with unmet needs. We have build a state-of-the art manufacturing site in the Netherlands (Hoofddorp),
About the Role:
As a Quality Engineer you will act as Quality reviewer or approver or creator for Validation Deliverables related to Kite Pharma working on the companies quality system
Requirements:- 5+ years of experience in Validation/Quality Role in GMP environment.
- Experienced as Quality Validation SME for projects and changes related to Computerized Systems, local and enterprise levels.
- Experience in Validation of MES, specifically Werum PAS-X.
- Has created, reviewed, approved Validation deliverables for multiple projects related to computerized systems.
- Fully understands the concept of a company quality system and the need to work within that system.
- Experience in Deviations, CAPAs, Change Control.
- In depth knowledge of GMP regulations/guidances/standards.
- Professional level of English, written and spoken.
- Willing to work extra time as required.