Quality Assurance Lead – Part-Time Section Head

LOCATION: Portsmouth    SALARY: Competitive  REF: ALS 2551

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Our client, a contract testing organisation, is looking for an experienced quality assurance professional, to lead departmental and external audits, with responsibility for GMP compliance. This is a permanent role and a very exciting opportunity to shape your future.

Hours and days are flexible and salary is commensurate with experience.

Essential Requirements:

  • Excellent GMP compliance with experience across multiple projects
  • Suitably qualified for this level of responsibility, preferably in scientific research
  • Proficient in ISO 9001 with either manual or automated experience in QMS
  • Demonstrable experience leading internal and external audits
  • Good leadership capabilities
  • Capable of providing sound advice on relevant quality matters.
  • Confidence in client-facing responsibilities
  • Able to manage and prioritise own workload effectively.
  • Promotes a positive, cohesive, team-orientated environment.
  • Experience in in vivo toxicology is desirable but not essential

Duties and Responsibilities

  • Undertake the role of GMP Champion within the department, promoting quality management tools and coordinating best practice across the company.
  • Contribute towards finalisation of new manual QMS, with responsibility for review and management
  • Ensure departmental work meets internal quality assurance documentation and accepted published guidelines or sponsor protocols
  • Ensure all relevant studies are carried out in compliance with GMP
  • Provide quality assurance support to departments and clients
  • Lead inspections of departments for compliance with GMP or other quality standards
  • Host internal and external inspections, regulatory and clients, reporting to appropriate personnel
  • Maintain the Company’s supplier approval procedures, inspecting vendors and sub-contract laboratories for approved supplier status.
  • Enforce quality assurance review of change control documents, investigation reports associated with non-conformance/out of specification and any associated CAPA
  • Conduct activities in accordance with site documents for H&S and quality systems.
  • Review regulatory updates including USP/EP and ISO.
  • Manage any DIRA reviews and process maps across the company.
  • Supervise collation of data for the preparation of reports and for compliance with Quality Procedures for work performed in the department.
  • Carry out GMP training of staff as required

Agenda only recruits people with integrity, who are honest and trustworthy and who have a great work ethic. To enable us to hire the very best people, we will conduct a comprehensive background and pre-employment screening, which is an essential part of Agenda’s recruitment process.


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