A growing biopharmaceutical company is looking for a QA/RA Officer to join their Regulatory Support team. You will be responsible for developing and maintaining the Regulatory Support Documentation and supporting both the Quality Department and clients in their regulatory submissions. You will require a scientific degree and previous experience in a Quality Assurance or Regulatory Affairs position.
- To ensure all Regulatory Support Files (RSFs) are relevant with current regulations and maintained
- To review and interpret R&D and TT reports, to identify the critical information and provide a written summary for the Product Regulatory Support Files.
- To set up access controls on the Regulatory Support Files to ensure confidentiality when required and to remove archived reports from general circulation.
- To identify gaps in the Regulatory Support Files and to feedback to relevant department to initiate work to enable the required data to be generated.
- To act as Regulatory support for the team and potentially other sites within the portfolio.
- To write Regulatory and Quality SOPs.
- To deal either directly or indirectly with Regulatory Authorities, Notified Bodies and Competent Authorities to ensure that the company meets all relevant requirements.
- To be main point of contact for Quality related matters in the Cambridge site.
- To support Quality including company sites globally.
- Act as an internal auditor of the Quality systems
- Scientific degree
- Several years in a Quality or Regulatory environment
- Good understanding of ISO 9001: 2015
- Experience in Regulatory affairs would be beneficial
- GMP experience preferable
- Experience in Lean Sigma preferable.
- Experience with Microsoft Office and Outlook.
- Ability to lead projects and meetings
You must have the right to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 7363
- Posted: 15th June 2022
- Expires: 13th July 2022