GCP Quality Assurance Specialist (Consultant)

Location
Berkshire
Salary
£300 to £400 per day
Posted
21 Sep 2017
Closes
19 Oct 2017
Ref
J4452
Contact
Georgia St John-Smith
Contract Type
Contract
Hours
Full Time
We are currently looking for a GCP Quality Assurance Specialist (consultant) to join a leading Life Sciences company based in the Berkshire area.

As the GCP Quality Assurance Specialist (consultant), you will be responsible for supporting the development of a Clinical Quality Management System (QMS).

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the GCP Quality Assurance Specialist will be varied however the key duties and responsibilities are as follows:

1. Work with corporate templates, translate requirements (graphs, meeting notes etc) into Standard Operating Procedures (SOPs) for each task in the Plan.

2. Use your Clinical Research Associate background or Clinical Coordination experience in order to coordinate the revision of the Quality Manual.

3. Ensure consistency between / streamlining of all SOPs and Quality Manual.

4. Support the development of MHRA pre-inspection dossier and participate in MHRA inspections as required.

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the GCP QA we are looking to identify the following on your profile and past history:

1. Relevant degree in a Scientific Discipline alongside a valid Good Clinical Practice (GCP) training certificate.

2. Proven industry experience in a CRO or Pharmaceutical Company.

3. A working knowledge and practical experience with the principles of ICH Good Clinical Practice as well as experience in Quality Assurance such as SOP and technical quality writing.
CRA / Clinical Coordinator background

Key Words: Clinical / GCP / Good Clinical Practice / MHRA / QA / Quality Assurance / Pharmaceutical / CRO / CMO / Biopharmaceutical / QMS / Quality Management System / Quality Manual / SOPs / Clinical Coordinator / CRA / Clinical Research Assistant

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for our talent development. We welcome applications for any applicant who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment processionals and scientists. We look forward to helping you with your next career moves.