Do you have experience with GMP and would you like to work in the world of cell therapy?This is a remote position where you will work as a coördinator for laboratory audits.
Function
For our client active in the newest cell therapy we are looking for a Coördinator of inspections and audits.
Tasks
- Assist the audit and inspections department with logistical coordination, documentation management, and operational activities related to internal and external audits and inspections.
- Ensure that all operational processes are in alignment with Good Practice (Gx.P) guidelines.
- Collaborate with internal and external stakeholders to resource and schedule audits, track timelines, generate Corrective and Preventive Action (CAPA) Plans and manage follow-up actions to closure.
- Provide day-to-day support to internal stakeholders, ensuring seamless operations and adherence to audit and CAPA plan timelines.
- Maintain accurate records of all audit and inspection activities and produce reports summarizing audit and inspection findings and operational insights.
- Support the preparation and logistics of regulatory authority inspections, as needed.
