Quality Engineer
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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.