Senior QA Engineer, MindCapture | VINDAZO in België

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Solliciteren

Plaats

Antwerp
België
België

Contract

Vooltijds, Onbepaalde duur

Datum gepubliceerd

2026-03-04

Online to:

2026-05-03
EUR 20.00 HOUR

Senior QA Engineer

MindCapture
België
16 uren geleden

ppAt 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. /ppYou can count on: /pulliThe chance to work on international healthcare projects that directly improve lives /liliCompetitive 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 /liliPersonalised training and development opportunities to shape your career path /liliA supportive environment where you choose what you love to do, build on your strengths and make a difference where it matters most /li /ulpThe 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. /ph3QA procedures and implementation /h3pDraft 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. /ppExecute supplier qualification activities including documentation review, quality agreements support and risk based assessments. Follow up actions with stakeholders to secure compliant supply chain readiness. /ppReview 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. /ph3Operational documentation review /h3pReview operational documents such as material specifications, incoming goods inspection records and related operating procedures. Confirm alignment with GMP expectations and CRF operational needs. /ph3Controlled copies and batch documentation /h3pManage controlled copies where required, including batch record versions and distribution controls. Ensure documentation remains consistent, approved and available to operations at the right time. /ph3Compliance and inspection readiness /h3pSafeguard 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. /ph3Required competences skills /h3ulliMaster’s degree in a scientific discipline such as engineering, chemistry, biomedical sciences or pharmacy /lili10+ years of relevant experience in a GMP environment across QA and validation /liliProven experience setting up and implementing new QA processes from scratch /liliExperience supporting start up of a new production facility is an advantage /liliProactive communicator with hands on mindset plus strong discipline to close actions to completion /liliAble to review technical and operational documentation with strong attention to detail /liliWilling to perform inspections in controlled environments where radioactive materials are handled, without direct exposure /li /ulpQuality Compliance Mol Senior Consultant at MindCapture /ph3About this application /h3pThis 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. /ppMindCapture 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. /ph3Job Contact – bTalent Business Team /b /h3pOur 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. /ppWhen a potential match is identified, one of our TB 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. /ph3How our application process works /h3ullibApply online /b – Submit your application in just a few clicks. /lilibPersonal interview /b – 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. /lilibClient introduction /b – We match you with potential projects and introduce you to clients where your expertise fits best. /lilibClient interview feedback /b – You meet with the client to explore project details and expectations, while we support you throughout the discussions and provide follow-up afterwards. /lilibFinal interview welcome /b – 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. /li /ulh3Explore other jobs in Quality Compliance /h3ulliBuild QA systems for radioisotope production project start up /liliPerform quality control testing for Actinium 225 release /liliWork safely with radioactive material under GMP standards /liliEnsure GMP compliant investigations, batch review, etc /liliCoordinate CAPAs, deviations and supplier quality /liliSupport audits, inspections, training, quality improvements /liliEnsure compliance in qualification and validation lifecycle /liliReview and approve critical QA validation documentation /liliAct as QA partner for engineering and system upgrades /liliExecute validation of GMP critical computerised systems /liliEnsure compliance with FDA and EU regulatory standards /liliGenerate validation documentation and resolve issues /liliMaintain and troubleshoot lab equipment in GMP setting /liliEnsure compliance with cGMP standards and safety guidelines /liliSupport upgrades and continuous improvement initiatives /liliPerform QC testing for cell therapy products /liliEnsure compliance with GMP and regulatory standards /liliCollaborate on tech transfer and quality documentation /liliDrive quality strategy for global computerised systems /liliEnsure validation in line with GMP requirements /liliLead audits, inspections and compliance risk assessments /liliBuild, implement and maintain Quality Management Systems /liliManage deviations, CAPAs and change control processes /liliPrepare for and support audits and inspections /li /ulpWe 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. /p /p #J-18808-Ljbffr

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