Description
Primary Tasks and Responsibilities:* 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.
* Carries out tasks related to the management of project and site change control systems:
* 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/technical discipline required
* A minimum of 4 years experience in a quality, validation or compliance role
* Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
* Knowledgeable of FDA/EMEA regulatory requirements
This is an urgent requirement with competitive hourly rates. If you are interested in applying please contact Sarah Irvine on or reply with a copy of your current CV.