At MindCapture you are not just taking on a new job, you are joining a community that values who you are and what you bring to the table.
You can count on:
* The chance to work on international healthcare projects that directly improve lives
* Competitive salary with a full package of extra-legal benefits including meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance and a company car
* Personalised training and development opportunities to shape your career path
* A supportive environment where you choose what you love to do, build on your strengths and make a difference where it matters most
The start up of a new project for medical radioisotope production requires a senior QA Engineer to ensure QA systems are in place, validation packages are approved and operational procedures are compliant and audit ready before first production.
QA procedures and implementation
Draft operational QA procedures for topics such as training, supplier qualification, internal audits and product release. Ensure the procedures are practical, compliant and ready for use before start of production.
Execute supplier qualification activities including documentation review, quality agreements support and risk based assessments. Follow up actions with stakeholders to secure compliant supply chain readiness.
Review validation plans, protocols, test evidence and reports to support validated status for equipment, systems, analytical methods and cleanroom conditions. Provide clear feedback to strengthen compliance, traceability and audit readiness.
Operational documentation review
Review operational documents such as material specifications, incoming goods inspection records and related operating procedures. Confirm alignment with GMP expectations and CRF operational needs.
Controlled copies and batch documentation
Manage controlled copies where required, including batch record versions and distribution controls. Ensure documentation remains consistent, approved and available to operations at the right time.
Compliance and inspection readiness
Safeguard compliance with Annex 1, Annex 3, Annex 11 and FDA 21 CFR Part 11 requirements throughout set up activities. Support audit readiness by ensuring robust documentation, clear rationale and timely closure of observations.
Required competences & skills
* Master’s degree in a scientific discipline such as engineering, chemistry, biomedical sciences or pharmacy
* 10+ years of relevant experience in a GMP environment across QA and validation
* Proven experience setting up and implementing new QA processes from scratch
* Experience supporting start up of a new production facility is an advantage
* Proactive communicator with hands on mindset plus strong discipline to close actions to completion
* Able to review technical and operational documentation with strong attention to detail
* Willing to perform inspections in controlled environments where radioactive materials are handled, without direct exposure
Quality & Compliance Mol Senior Consultant at MindCapture
About this application
This opportunity is offered through MindCapture as a consultancy role with strong day to day ownership. You will be placed on site with our client in Mol, working closely with the CRF team to build quality systems, review validation deliverables and strengthen operational readiness ahead of first production.
MindCapture supports you throughout your assignment with clear onboarding, regular follow up plus access to learning opportunities. You will have a single point of contact, transparent communication and the support needed to deliver impact in a structured and compliant way.
Job Contact – Talent & Business Team
Our Talent & Business Managers combine a deep understanding of our clients’ needs with a sharp eye for talent. Their focus is on creating meaningful and sustainable matches, always keeping both the role and the candidate in mind.
When a potential match is identified, one of our T&B colleagues may reach out to answer your questions, share additional context about the role and discuss possible next steps together, with clarity and transparency throughout the process.
How our application process works
* Apply online – Submit your application in just a few clicks.
* Personal interview – If we see a potential match, our team reaches out to get to know you better, explore your skills and ambitions and hear what you value in your next challenge.
* Client introduction – We match you with potential projects and introduce you to clients where your expertise fits best.
* Client interview & feedback – You meet with the client to explore project details and expectations, while we support you throughout the discussions and provide follow-up afterwards.
* Final interview & welcome – In a final chat with our team, we close the process and warmly welcome you to MindCapture, guiding you towards a smooth start with us or at the client site.
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We know timing is everything. If you don’t see a role that fits you right now, we still want to hear from you. Our consultants are always looking for talent, sometimes before the job even goes live. Drop us your CV and we’ll keep you in mind for future opportunities.
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