We are currently looking for a Quality Assurance Auditor to join a fast growing CRO based in the Macclesfield area. As the Quality Assurance Auditor you will be responsible for assuring management that the facility is operating in compliance with the UK regulations by participation in audits, data and report reviews.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Quality Assurance Auditor will be varied however the key duties and responsibilities are as follows:
1. The QA Auditor will advise Test Facility Management and give general assistance in relation to the
compliance programme as well as audit documents and scientific data to ensure that the regulatory studies are planned, executed, and reported fully and accurately.
2. You will maintain an awareness of the requirements of GLP and laboratory GCP current thinking/regulatory guidance worldwide whilst perform 3rd party supplier audits in order to monitor quality practices and standards.
3. Another responsibility will be to communicate effectively and maintain robust knowledge of the requirements of GLP and laboratory GCP current thinking/regulatory guidance worldwide.
4. You will be responsible for inspections of the study procedures, laboratory processes and facilities
interacting with staff at all levels. You will also deliver regulatory training for all staff at the business to ensure an awareness of GLP and laboratory GCP.
To be successful in your application to this exciting opportunity as the Quality Assurance Auditor we are looking to identify the following on your profile and past history:
1. Relevant degree in Life Sciences or Chemistry related discipline is required.
2. Proven industry experience in auditing in a relevant or relatable quality standard (GLP, GCP. GMP, ISO) is essential.
3. An eye for detail and the determination to complete tasks to a high standard within tight deadlines is desirable.
Key Words: Quality Assurance | Auditor | GLP | GCP | GMP | Data | Laboratory | Documentation |