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Senior Quality Assurance auditor- clinical trials

Central London   •  £53,000 - 55,000  •  Permanent, Full time


Senior Quality Assurance Auditor

London based

Permanent position

55,000 salary, 25 days holiday, 6% employer pension, x3 life assurance

An exciting opportunity to join a company specialising in conducting human challenge studies, where services to both pharmaceutical and biotechnology companies use a variation of different clinical trial methodologies across the differing viral challenges. Their main focus as a company is to completely eradicate common illnesses like the flu and cold. The role responsibility as a senior quality assurance auditor is to ensure the company complies with the relevant SOPs, regulations and internal regulation guidelines such as GCP.

Main Responsibilities:

Plan and conduct assigned audits

Assess compliance with Quality management systems

Maintain up to date knowledge of regulations, guidelines and the companys SOPs

Plan and conduct follow up of audits of high-risk suppliers

Internal Audits:

Plan and produce audit plans and detail scope of the audit

Plan audit of review in comparison to previous audit reports and relevant up to date legislation

Conduct allocated system, process, facility, study, document and data audits by review of relevant documentation as well as attention to detail on relevant procedures and tours

Present audit findings to colleagues

Conduct peer reviews of colleagues audit reports to ensure accuracy and appropriateness of findings and classification of findings.

Conduct QA review of SOPs and associated Master Forms as part of review and approval system within QuMas;

Plan, conduct and follow up audits across all business areas within hVIVO and all audit types and document types (laboratories, clinical, data management, computer system validation)

Audits of Suppliers and Subcontractors:

Plan, conduct and follow up allocated remote (questionnaire and due diligence) audits;

Compile relevant questions to assess compliance of service being provided;

Assess information provided or sourced to provide decision on suitability of supplier or subcontractor to provide services to the company and add to QA approved suppliers list;

Plan, conduct and follow up onsite audits in line with the supplier audit plan;

Act as Lead Auditor to plan, conduct and follow up on-site audits of suppliers and subcontractors in line with the supplier audit plan;

Liaise with relevant hVIVO staff requesting use of the supplier or subcontractor to ascertain scope of the audit required.

Skills & Experiences:

Degree in Science or equivalent

Proven knowledge of drug development processes

Excellent knowledge of GCP and GCP for laboratories regulatory standards

Working knowledge of GLP and GMP standards

Proven communication skills with the ability to communicate with all levels within hVIVO

A pragmatic and diplomatic approach to problem solving

Excellent attention to detail

GCP or GCP for laboratories experience in pharmaceutical or CRO

Quality assurance auditing and quality system experience

Please note, this company works with a range of respiratory viruses as part of our day to day operation, including Covid-19. Your suitability will be assessed as part of the interview process from a health and safety perspective and it is recommended you consider your own health and those of family members (clinically vulnerable and shielding) when considering to apply for this role.

To apply contact:

Hanan.gibson@cpl.com | 0118 952 2798

  • Agency: Cpl Life Sciences
  • Contact: Hanan Gibson
  • Reference: JO-2109-477281
  • Posted: 29th September 2021
  • Expires: 27th October 2021

Cpl Life Sciences

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