Subject Matter Expert / Project Lead Commissioning & Qualification

Subject Matter Expert / Project Lead Commissioning & Qualification

• 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.

Organisatie- en afdelingomschrijving

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!

Meer informatie over deze vacature

Ken Falorni Sr. Recruitment Consultant
Wat is mijn reistijd?