Oorspronkelijke vacature omschrijving:
Over de werkgever
Our client, which is a leading international biotechnology company that works in the field of cell and gene therapy, is looking for a Quality Assurance (QA) Project Manager for their manufacturing laboratory in Geleen. The company has experienced enormous growth over the past few years and wants to continue this growth over the next years. Its work has a direct impact on the patients in need of cell therapy.
Functie
As a QA Project Manager, you are the primary contact person / account manager for external customers for all quality-related items. You act as the quality expert for change controls, CAPAs, deviations, stand-alone investigations, product quality reviews and quality agreements. You are responsible for meetings between the customers and internal groups such as manufacturing, engineering, QC and others. You are mainly responsible for…
- Supporting deviation, investigation and CAPA processes specific for a customer
- Reviewing and approving investigation reports including root cause analysis and assuring corrective and preventive actions to prevent recurrence
- Facilitating discussions between internal groups and the customer
- Tracking and presenting customer metrics
- Supporting customer audits
- Tracking KPIs
Functie-eisen
- Significant working experience in QA operations or a similar discipline (± 7 years is preferred)
- Significant working experience in a GMP environment with the associated regulations
- Significant working experience with project management
- 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
- Proven organizational skills
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 Twan Ackermans at +31 6 39 89 11 30.
Solliciteren
We look forward to receiving your application. You can apply via the ‘apply’ button or by contacting Twan Ackermans at +31 6 39 89 11 30.
