Oorspronkelijke vacature omschrijving:
Introductie
The company
Our client is a global organization, focused on achieving the strategic vision of being the world’s leading, integrated solutions provider in pharma and consumer healthcare and nutrition customers all along the healthcare continuum. The company has more than 100 sites and offices and approximately 14,500 full-time employees worldwide. We are looking for a junior biotech associate to work at one of the company’s sites located in the south of Limburg Province, the Netherlands.
Functie
The Quality Assurance (QA) Validation manager leads a team of professionals to carry out variety of tasks related to the validation of equipment and facilities.
The QA validation manager is instrumental in achieving this goal through development of team goals, daily management of team assignments and ensuring continuous application of the proper requirements
Key responsibilities:
- Work to identify efficiencies in the validation program approach. Work to apply lessons learned, and stay informed of industry regulatory changes as it applies to equipment / facility validation.
- Perform assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA’s.
- Present and defend the validation program and acceptance criteria to client and regulators.
- Review and revise the Validation Master Plan as necessary to ensure GMP compliance with all applicable regulations and guidelines.
- Support the Quality Engineering group to maintain the validation maintenance program.
- Train and mentor validation staff with respect to equipment and facility validation/qualification.
- Perform other duties as assigned.
Functie-eisen
- Excellent technical writing skills and the ability to document all work in a thorough, accurate and timely manner.
- Excellent written and oral communication skills and the ability to work interdepartmentally in an effective manner to carry out daily duties.
- Excellent organizational and time management skills
- Provides training and mentoring to the validation team as well as other departments as necessary to accomplish the goals of the validation program.
Het aanbod
- A high tech work environment.
- Career growth possibilities.
- Very good comansation package
- Modern secondary conditions of employment (pension scheme, 8% holiday allowance, end-of-year bonus).
If you do not already live in the south of Limburg region, you have to be willing to relocate. Depending on your circumstances, you will be eligible for an allowance to help cover your moving costs.
Informatie
Please contact Robin Bisschoff (+31 6 14 79 56 47) if you have any questions about this position.
Solliciteren
Please apply via the “Apply” button. We are looking forward to receiving your application!