Introduction
Our client is an innovative company focused on developing CAR-T immunotherapies for the treatment of cancer. This cutting-edge approach utilizes point-of-care cell therapy, resulting in efficient treatments and better patient outcomes. The organization offers a modern and dynamic working environment in a new building.
Job Description
As an Audit Coordinator, you will be responsible for supporting the audit and inspection department in coordinating logistical processes and managing documentation. You will ensure that all operational activities comply with Good Practice (GxP) guidelines. Additionally, you will collaborate with various stakeholders to schedule audits, track timelines, and generate and manage corrective and preventive actions (CAPA). You will maintain accurate records of all audit and inspection activities and produce reports summarizing findings and operational insights.
Responsibilities
- Support the audit and inspection department with logistical and operational tasks.
- Ensure compliance with GxP guidelines in all operational processes.
- Collaborate with internal and external parties to schedule and track audits.
- Generate CAPA plans and follow up on actions until closure.
- Maintain accurate audit and inspection documentation and prepare reports.
Profile
- Bachelor's degree in Life Sciences or a related field.
- Minimum of 3-4 years of experience in a biotech, pharmaceutical, or CRO environment with a focus on GxP compliance.
- Knowledge of GxP areas such as GMP, GDP, GCP, and GLP, as well as regulations in the EU, US, and other regions.
- Strong organizational skills and attention to detail.
Employment Conditions
- Salary depends on the experience and background of the candidate.
- Contract type: Contract through Oxford
- A challenging role for professionals with audit experience who enjoy coordinating projects.
- A dynamic work environment with opportunities for professional growth.
- Vacaturenummer: 25149
