1 year contract hybrid Job Model French speaking desired
Are you passionate about bridging IT and Quality in a highly regulated environment We are looking for an experienced Life Science professional to take on a pivotal role ensuring IT compliance and quality oversight across complex manufacturing systems.
What youll do
- Act as the key contact between IT and Quality fostering a strong quality culture.
- Ensure compliance of site IT systems with GxP EU-GMP Annex 11 and 21 CFR Part 11.
- Lead Computer System Validation (CSV) activities and support data integrity programs.
- Translate compliance requirements into test strategies (FAT SAT IQ OQ PQ).
- Partner with cross-functional teams and external stakeholders to drive compliance and continuous improvement.
- Support audits infrastructure integration and remediation projects.
What you bring
- A degree in Life Sciences Quality Engineering or related field.
- 510 years of experience in the pharmaceutical biotech or life science industry with at least 5 years in IT compliance validation or quality roles.
- Solid knowledge of Quality Management Systems GxP systems (MES LIMS etc.) and Data Integrity.
- Strong IT foundation (OS infrastructure networking systems).
- Expertise in CSV and regulatory frameworks (21 CFR Part 11 EudraLex MHRA).
- Excellent communication skills a structured and analytical mindset and the ability to thrive in an international multidisciplinary environment.
Why join
This is a unique opportunity to contribute to high-impact manufacturing operations ensuring compliance data integrity and patient safety. Youll work in a dynamic environment that values ethics collaboration and continuous learning.