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Quality Manager – Edinburgh (with travel to Dundee)

The Company

Concept Life Sciences is a knowledge based, science led business focused on delivering the services, expertise and capabilities our clients require.  Our business is focused on several core sectors including pharmaceutical, biotechnology, food, environmental, agrochemical, petrochemical, chemical and consumer products industries. We support drug research, discovery and development to our pharmaceutical and biotechnology clients; provide testing and specialist analytical services and consultancy to the pharmaceutical, food and environmental sectors, toxicology services to the pharmaceutical, chemical, agrochemical and consumer products industries and materials chemistry services to the petrochemical industry.  Concept is part of the Spectris Group.   www.spectris.com.

 

The Role

The successful candidate will be based in Edinburgh, with regular travel to Dundee. They will be required to further develop and maintain the Quality Assurance Programme for GLP and Good Clinical Practice (GCP) and perform the independent monitoring for compliance with the current regulations at Concept Life Sciences. This role is also required to take the lead and train operational staff in the requirements of GLP and GCP.

 

Main Duties to: 

  • Assume responsibility for the maintenance of the QA programme in accordance with current regulations and guidance.
  • Assume responsibility for the day to day management of QA functions.
  • Perform all aspects of GLP and GCP monitoring of work conducted.
  • Review the QA programme to ensure it meets regulatory requirements and is of maximum benefit, reporting any deficiencies to the VP of Quality and Test Facility Management.
  • Develop or improve, in conjunction with the VP of Quality and colleagues across Concept sites, auditing strategies for new systems introduced at Dundee or other sites as required.
  • Work with site Management to ensure GLP/GCP standards are maintained.
  • Develop in conjunction with the VP of Quality and colleagues across Concept sites and deliver formal GLP and GCP training.
  • Act as QA contact for site.

 

Qualifications/Role Requirements: 

  • Proven knowledge, skills and abilities in managing GLP and GCP systems and Regulatory Requirements.
  • Scientific background
  • Excellent organisational, interpersonal and communication skills.
  • Competent at preparing and delivering presentations to employees, customers and regulatory bodies.
  • Strong management skills and ability to lead a team through change.
  • Proven ability to challenge and drive quality and a compliant culture forward.
  • Experience in influencing, impacting and leading QA operations through developing audit schedules, training initiatives, QA recruitment.
  • Ability to investigate and review information and draw conclusions in support of CAPA, deviations etc.

 

Working Hours

  • Full time – 37.5hrs per week – Flexibility is required, some weekend work may be needed and earlier or later start, and finish times may also be required.
  • There may be the opportunity to work across the company’s laboratory sites.

 

Company Benefits

We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard.  In our science-based roles we offer structured career progression, more details of which can be discussed during the recruitment process.  In addition to a competitive salary, we offer as a minimum: Pension scheme, Share Save scheme, Healthcare Cash Plan, Retail Discount scheme and a Cycle to Work scheme.

 

Apply for Quality Manager – Edinburgh (with travel to Dundee)