Description
Primary Tasks and Responsibilities- Supports the management of GMP compliance systems.
- Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
- Carries out tasks related to the administration of project and site nonconformance management systems.
- Reviews and/or approves nonconformance investigations and their associated documentation.
- Manages entry of nonconformance records into the appropriate electronic system.
- Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
- Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
- Approves closure of nonconformance investigations on completion of the investigation and associated corrective actions.
- Reviews and/or approves change control requests, implementation actions, and request closures.
- Manages entry of change control records into the appropriate electronic system.
- Tracks records from the initiation through closure processes and advises relevant
Qualifications and Experience:
- Bachelors Degree in a scientific discipline required
- A minimum of 6 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
If you would like to apply please contact me on or reply with your most recent CV.
Or if you know of anyone who may be suitable for the position we also offer €200 worth of shopping voucher for successful referrals. Perfect for Christmas shopping!