Quality Engineer

Il y a 3 heures

Geel, Flanders, Belgique R Dpartners Temps plein
pAre you ready to turn precision into progress and play a key role in shaping the future of pharmaceutical innovation? /ppRD Partners is seeking a Quality Engineer to oversee and ensure the quality of third-party computerized systems providers. This role involves evaluating suppliers, maintaining compliance with regulations, and driving continuous improvement initiatives. You will play a key role in ensuring that third-party systems meet quality standards and regulatory requirements. /ppPlease note that to be considered for this role you must have the right to work in this location /ph3bResponsibilities: /b /h3ulliAssess third-party computerized systems providers, either remotely or on-site, to ensure they meet legal and quality standards. /liliConduct risk-based evaluations to determine the necessary level of quality control and oversight. /liliDevelop and maintain quality agreements and contractual clauses with suppliers. /liliRegularly update the list of approved third-party providers in the database. /liliMonitor the performance of third-party providers and recommend improvements. /liliKeep accurate records of all quality-related activities. /li /ulh3bKey Skills and

Requirements:
/b /h3ulliExperience in a regulated environment focusing on third-party quality management. /liliUnderstanding of computerized systems validation (CSV) is a plus. /liliFamiliarity with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5. /liliStrong analytical and risk assessment skills. /liliProficiency in Dutch and English, both written and spoken. /liliA degree in Life Sciences, Engineering, Computer Sciences, or a related field is preferred. /li /ulh3bSalary: /b /h3ulli€450 to €487 per day. /li /ulpFor more information, please contact bMandi Cakwe. /b /p