• FAT / SAT, IQ-OQ-PQ design, reviews.

• Contact with clients : writing design plans and bring criticism and improvement-oriented advice.

• Part of the transdermal unit in sterile production, vials, syringes filling, liquids, shampoos, creams, eye drops,...

• Lead Commissioning and Qualification (C&Q) projects for our clients in the pharmaceutical, biotechnology, and medical device industries.

• Manage the overall project timeline, scope, and budget.

• Develop C&Q documentation, protocols, and reports.

• Develop and maintain relationships with clients and stakeholders.

• Review and approve C&Q documentation, protocols, and reports.

• Ensure that C&Q activities are performed in compliance with all applicable regulations.

• Provide technical expertise and guidance to project team members.

• Train and mentor junior C&Q staff.

• Contribute to the development of best practices, standards, and templates related to C&Q.

• Academic diploma (BSc / MSc) in Life Sciences.

• QA production background welcome.

• At least 5 years of relevant experience (sterile production, pharma).

• Isolators knowledge required.

• Able to handle multiple tasks and priorities.

• Dutch as mother tongue, good knowledge of English, French optional.

• Strong analytical thinking.

• Team player and hands-on.

In today's environment, the healthcare sector faces major challenges in terms of regulation/legislation and the reliability of processes. At the heart of this whole thing is the health and well-being of the patient and the ever-present need to make cost savings.

Our client is looking for a SME Project Lead (m/v/x) Commissioning and Qualification.

• You are part of a technology-driven team.

• We offer you an international environment, where self-development is central!

• Room to further develop your career.

• You are also assured of a long-term contract with fringe benefits such as a laptop and mobile phone, company car with fuel card, meal vouchers, eco vouchers, hospitalization and group insurance and the option of working from home!