QA Engineer Thrid Party

Il y a 1 heure

Antwerp, Flanders, Belgique Akkodis Temps plein
pAkkodis is a global digital engineering and smart industry leader, bringing together talent and technology to engineer a smarter future. With more than 50,000 experts worldwide and over 1,000 in Belgium, we support companies across industries in innovation, digital transformation and RD; from consulting and talent solutions to end-to-end project delivery. Driven by passion, expertise and impact, we make incredible happen. /ppIn Belgium, we operate through 7 dedicated practices, where our consultants receive the technical guidance, coaching and support they need to grow and fully unlock their potential. We believe in empowering our talent by providing the right expertise, knowledge-sharing and development opportunities to help them thrive. Our practices: Product System Development, Validation Verification, Manufacturing Operations, Cloud Infrastructures Security, Data Analytics Artificial Intelligence, Digital Software and Wireless Connectivity. /ppAkkodis is part of the Adecco Group. You can find more information on our website : /ppYou will support the qualification and ongoing quality oversight of third-party computerized systems providers. In this role, you will assess provider legality, suitability, and competence in line with client requirements and local regulations, while also supporting risk-based evaluations, quality agreements, and documentation controls. The position requires close attention to computerized systems quality management, third-party oversight, and regulatory expectations in a GxP-regulated environment. /ph3Your responsibilities /h3ulliPerform qualification assessments of third-party computerized systems providers, on-site or remotely, in line with Sanofi requirements and local regulations. /liliConduct risk-based evaluations of CS third parties to determine the appropriate level of quality control and oversight. /liliReview related external audits as part of the evaluation of third-party quality and compliance performance. /liliDevelop, negotiate, and maintain quality agreements and contractual quality clauses with third-party suppliers. /liliMaintain and update the qualified CS Third Party list in the referential database at least twice yearly. /liliMonitor routine quality performance of qualified third parties and support continuous improvement initiatives. /liliEnsure accurate documentation and record-keeping for all third-party quality activities. /li /ulh3What skills do you bring to the table? /h3ulliAt least 2 years of experience in a GxP-regulated environment with a focus on third-party quality management. /liliKnowledge of computerized systems validation (CSV) is an asset for this position. /liliFamiliarity with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 is required. /liliStrong analytical skills and the ability to perform structured risk assessments. /liliFluency in Dutch and English, both written and spoken, is required. /liliBachelor’s or Master’s degree in Life Sciences, Engineering, Computer Sciences, or a related field is preferred. /li /ulh3Our recruitment process /h3pStage 1: Initial telephone interview (15 min) with @Bo, Talent Acquisition Specialist. /ppStep 2: Interview (60 min) with a Business Manager. /ppStep 3: Interview (60 min) with the client. /p