Quality Officer

Description

Department

Qualification & Maintenance is primarily responsible for the qualification and maintenance of laboratory equipment for various divisions within the organization. This position is to review and approve the department protocols and procedures and is responsible to support change management and deviation management processes.



Responsibilities:



- Review and approve qualification documents for the three main systems: IT, Process- and lab equipment.

- Review and approve Change Control Records and Deviation Records.

- Advise customers and ensure a proper implementation of the qualification strategy.

- Reporting with regards to the above processes and offer advice on improvements.



 Requirements:



- Bachelor / Master's degree.

- Proven, relevant work experience in validation / qualification of process equipment and / or utilities and / or IT validation.

- Experience working in lab (equipment) validation is an advantage.

- Strong experience working in a GMP manufacturing environment.

- Knowledge and experience working with QMS.

- Good knowledge of Dutch and English is required for this role.

- Experience with audits is advantageous.



Competencies:



The team within Qualification & Maintenance is very committed to their work and maintain a good work atmosphere. The following key skills are necessary to fit in well:



- Communicative

- Assertive

- Pro-active

- Driven

- Flexible

- Independent