Location: Hoofddorp(Amsterdam area)
Duration: 9 months with a possibility of extension
Industry: FMCG, chemicals or pharmaceuticals
Our client is a global healthcare company focused on development of innovative cancer immunotherapies with a goal of providing rapid, long-term durable response and eliminating the burden of chronic care by providing maximum access of cancer treatment to patients with unmet needs.
As a Quality Engineer you will act as Quality reviewer or approver or creator for validation deliverables by working on the companies quality system
- Minimum 5 Years’ experience into 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.