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Permanent Positions

QA Officer/Manager
London, London

In this role as a QA Officer, you will be responsible for the QA programme for our respected clients working within the life science sector. The successful candidate will manage, shape, and embed a quality culture within the organisation. The role of the QA Officer / Manager is to assure management that all the CRO and R&D research activities are performed in compliance with GLP and applicable GCP regulations, guidance, and expectations, and ensure a permanent state of inspection readiness. The QA Manager / Manager will assure the compliance of our client’s facilities, data integrity, staff training records, Standard Operation Procedures (SOPs), final study reports and foster the culture of quality throughout the organisation.

 

The role holder must have:

  • A Bachelor or above degree in Life Science or related subjects or equivalent quality-oriented education and training
  • Minimum 2 years work experience in Quality Assurance in a GLP environment, preferably in the Pharmaceutical CRO sector
  • An expert knowledge of GLP in pre-clinical toxicology, and GCP as it relates to clinical laboratories
  • A strong understanding of Computer Systems Validation in a GLP environment
  • Experience in hosting and participating in MHRA GLP inspections is desirable
  • The ability to promote regulatory awareness throughout the organisation
  • Strong analytical and training skills.
  • The ability to perform under pressure and know how to monitor progress
  • An excellent command of English, spoken and written
  • A strong team spirit and a mindset focused on quality and integrity

 

Responsibilities:

  • Lead and manage the audit program for GLP for Laboratories
  • Communicate the outcome of all quality assurance activities to the management team
  • Plan, design and perform inspections of the laboratory facility, systems and processes, and audit final reports for global GxP and SOP compliance
  • Manage CAPA systems to ensure all quality issues are corrected effectively
  • Develop robust Quality Assurance SOPs
  • Support the production of regulatory compliant policies and SOPs across the organisation
  • Manage the programme of quality oversight for external vendors
  • Ensure the organisation is always inspection and audit ready
  • Host and facilitate client and regulatory inspections
  • Keep abreast of changes to global regulations, guidance, and expectations
  • Provide staff training on current and new quality and compliance requirements
  • Maintain current knowledge of standard requirements according to GLP but can extended to GCP, GMP, CAP, ISO17025 and ISO 15189 guidelines related to the business process
Salary: £50,000 - £60,000 pa
Date Posted: 18/07/2022
  • S3Science is an equal opportunities employer: our recruitment process is fair, objective and open.

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