Description
Primary Tasks and ResponsibilitiesSupports the management of GMP compliance systems through the following activities:
* 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.
* 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 2 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.
* Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
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. We also offer vouchers for any successful referrals so if you know of anyone who may be looking please feel free to get in touch.