Quality Engineer

Il y a 3 jours

Geel, Antwerpen, Belgique R Dpartners Temps plein 83 000 € - 90 000 € Contrat

Are you ready to turn precision into progress and play a key role in shaping the future of pharmaceutical innovation?

R&D 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.

Please note that to be considered for this role you must have the right to work in this location

Responsibilities:

  • Assess third-party computerized systems providers, either remotely or on-site, to ensure they meet legal and quality standards.
  • Conduct risk-based evaluations to determine the necessary level of quality control and oversight.
  • Develop and maintain quality agreements and contractual clauses with suppliers.
  • Regularly update the list of approved third-party providers in the database.
  • Monitor the performance of third-party providers and recommend improvements.
  • Keep accurate records of all quality-related activities.

Key Skills and Requirements:

  • Experience in a regulated environment focusing on third-party quality management.
  • Understanding of computerized systems validation (CSV) is a plus.
  • Familiarity with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Strong analytical and risk assessment skills.
  • Proficiency in Dutch and English, both written and spoken.
  • A degree in Life Sciences, Engineering, Computer Sciences, or a related field is preferred.

Salary:

  • €450 to €487 per day.

For more information, please contact Mandi Cakwe.