Quality Engineer, Third-Party CSV & Compliance (Pharma)

R Dpartners; Geel; Hybrid; EUR 83,000 - 90,000; Full time

Job summary

R&D Partners is seeking a Quality Engineer to oversee and ensure the quality of third-party computerized systems providers, evaluating suppliers, maintaining compliance, and driving continuous improvement initiatives.

You will assess systems, manage risk, and develop quality agreements with suppliers, with Dutch and English proficiency and a life sciences/engineering/CS degree preferred.

Qualifications

• Experience in a regulated environment focusing on third-party quality management.
• Knowledge of CSV is a plus.
• Familiarity with 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 related field preferred.

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.

Skills

Quality management

Regulatory compliance

Risk assessment

Analytical skills

Dutch

English

Education

Life Sciences/Engineering/CS degree

Tools

CSV knowledge

Job description

R&D Partners is seeking a Quality Engineer to oversee and ensure the quality of third-party computerized systems providers, evaluating suppliers, maintaining compliance, and driving continuous improvement initiatives.

You will assess systems, manage risk, and develop quality agreements with suppliers, with Dutch and English proficiency and a life sciences/engineering/CS degree preferred.