Compass Life Sciences have teamed up with an exciting early stage Biotech specialising within infectious and respiratory diseases to support their search for a Senior Quality Assurance Auditor in London with GCP to work closely within their clinical trials.
The key purpose of the role is to ensure that the business is following the relevant procedures, regulations and internationally recognised guidelines. Therefore, the successful applicant will conduct audits of all systems, processes, facilities, documents, and studies and of our client's suppliers and subcontractors in order to deliver the audit programme as required by GCP.
- Plan and conduct assigned audits of processes, systems, facilities, studies and documents including protocols, reports, and computer system validation documents in line with the annual audit programme and appropriate study audit plans to verify compliance and determine the effectiveness of the company's quality systems and procedures with agreed timescales.
- Plan and conduct assigned audits of low to medium risk suppliers and subcontractors to our client by conduct of remote audits.
- Plan, conduct and follow up of audits from high-risk suppliers performed at the suppliers on site premises.
- Follow up and close out all assigned audits including agreement of appropriateness of corrective actions to audit findings with relevant members of the team.
- Assess compliance with our clients Quality Management System and ensure appropriate actions are agreed and followed up.
- Maintain an up-to-date knowledge of the current regulations, guidelines, and company procedures.
Skills & Experiences
- Degree in relevant field or equivalent
- Proven knowledge of drug development processes
- First-class knowledge of GCP and GCP for laboratories regulatory standards
- Working knowledge of GLP and GMP standards
- Proven communication skills with the ability to discuss key topics with all levels
- A rational and diplomatic approach to problem solving
- Superb attention to detail
- GCP experience in pharma or CRO
- High level of quality assurance auditing and quality system experience
If you are interested in learning more about this role, or would like a confidential exploratory conversation, contact Brandon Kersley today at BKersley@compassltd.co.uk, or call +44 (0)2392 316039 or +44 (0)7802624497.
Compass Associates Ltd trading as Compass Life Sciences is acting as a Recruitment Consultancy for this permanent vacancy; we offer £200 worth of John Lewis Vouchers for each successful recommendation.