Oorspronkelijke vacature omschrijving:
Over de werkgever
Our client, which is a big, international company that works in the field of cell culturing, is looking for a Senior Quality Assurance (QA) Officer for their manufacturing laboratory in Geleen. The company has experienced enormous growth over the past few years and wants to continue this growth for the next years. Its work has a direct impact on the patients in need of cell therapy.
Functie
As a Senior QA Officer, you are responsible for identifying and resolving quality issues that might affect the manufacturing process. Other tasks include maintaining proper documentation of any information that is relevant to the quality of the manufacturing proces. You are mainly responsible for…
- Reviewing and approving deviations, CAPAs and CRFs
- Reviewing and approving non-DMS documents
- Interacting directly with internal customers on change, CAPA and deviation management
- Serving as a decision-maker for change management throughout the facility
- Consulting with quality management on decisions to ensure alignment and agreement
- Training employees on basic quality tasks
Functie-eisen
- Significant working experience in QA operations or a similar discipline (± 5 years is preferred)
- Significant working experience in a GMP environment with the associated regulations
- Background in biomedical sciences, biotechnogy or related fields
- Experience working in an ATMP-environment or in a cleanroom is preferred
- Experience with Trackwise, SAP and a document management system is preferred
- Excellent written and verbal communication skills
- Pays close attention to detail
- Able to manage multiple activities within agreed upon timeframes
- No objection to working in shifts
Het aanbod
- Working in an international, multicultural organisation
- Excellent opportunities for growth and development as the company continues its growth
- A bonus of 10%
- A travel allowance
- 29 vacation days per year
Informatie
If you have any questions, please contact Robin Bisschoff at +31 6 14 79 56 47.
Solliciteren
We look forward to receiving your application. You can apply via the ‘apply’ button or by contacting Robin Bisschoff at +31 6 14 79 56 47.