Functie overzicht (doel van de functie) - Function Overview (purpose of the function)

The QA Gowning Qualification Trainer is part of a team responsible for performing training and qualification activities of a new grade B gowning method using re-usable gowning.

Belangrijkste verantwoordelijkheden - Major Responsibilities

The QA Gowning Qualification Trainer combines hands-on training and qualification of all grade B gowning qualified personnel for a new gowning method using re-usable gowning. Major responsibilities are:

· Become qualified for the new grade B gowning method using re-usable gowning and become an expert in the new gowning method.

· Work in 4d shift regime (4 days on, 4 days off, in a 7h-17h or 8h-18h shift) to:

· Provide training in the new grade B gowning method to all required personnel in a training environment (0,5 to 1 day per shift).

· Perform qualifications of the new grade B gowning method for all required personnel on the shop floor in Grade B cleanrooms (3 to 4 days per shift).

· Schedule all required personnel for their training and qualification sessions.

· Follow up on predefined timelines and resources needed to meet these timelines.

· Collaborate closely and follow up with other QA Gowning Qualification project members (up to three per shift).

· Communicate clearly to management about progress of the training and qualifications.

· The QA Gowning Qualification project members will be supported by the Training, QPIP and QA Micro teams. However, it is expected that the team members can perform most tasks independently and can self-organize the gowning training and qualification sessions.

Vereiste kennis en vaardigheden – Required Knowledge and skills

Education:

· Bachelor’s or Master’s degree in Biomedical Laboratory Technology or related scientific field or equivalent experience required.

Experience:

· Experience within the biological and/or pharmaceutical industry with relevant aseptic experience related to manufacturing is preferred.

· Educational background and/or training experience within a GMP or scientific industry environment is preferred.

· Experience with Learning Management Systems and working in a digital Quality Management System is an asset.