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Quality Assurance Officer
Gosport, South East

We are thrilled to offer a new, exciting opportunity to work with our client, a toxicology contract testing laboratory that supports pharmaceutical companies, vaccine researchers and manufacturers, biopharmaceutical startups and their investors, and chemical and agrochemical manufacturers in the essential work of ensuring their products meet regulatory safety requirements.

 

Job Summary


An exciting opportunity exists for an experienced and qualified professional to join our regulatory toxicology laboratory in Gosport, near Portsmouth, as Quality Assurance Officer. This is a permanent full-time role with the option of occasionally working from home.

 

As the company grows and the QMS develops, there is an excellent opportunity to get involved with quality process design to improve existing procedures about lean working.

 

You will be joining an independent contract testing laboratory at a time of significant growth, with a dynamic team that combines impeccable scientific credentials with a passion for animal welfare and implementation of the 3 Rs.

 

The Role


The Quality Assurance Officer will provide guidance and support to the operational side of the business to ensure governance, compliance, operational performance, and continuous improvement as the company grows its testing and analysis services portfolio.

 

You will work alongside our team of scientists and technicians in a non-laboratory role under the guidance of the Quality Assurance Manager to ensure our in vivo toxicological assays and tests meet accepted published guidelines or sponsors’ protocols and are carried out in compliance with GMP regulations and the policies and procedures of our internal Quality Management System (QMS).

 

What you will be doing


  • QA review of inspection of procedures, protocols, reports, CofAs, study plans and other data across our laboratory and animal facilities to ensure that reported results from our studies are complete and accurate
  • Managing the Supplier Approval programme
  • It is supporting the execution of all aspects of the QMS. This includes Change Control documentation, non-conformance investigation reports, deviations, complaints or out-of-specification results, CAPAs, data integrity reviews, and associated process maps.
  • Supporting external regulatory and client audits and reporting on these
  • Executing internal audits
  • Providing support and advice to other departments and clients on all aspects of Quality and compliance
  • Providing advice, supervision, and assistance in training laboratory staff on Quality related issues
  • Other related duties as required and assigned

 

What we expect from you


  • Experience working within a GMP or similar regulated industry
  • Knowledge of Quality Management principles, tools, and methodologies
  • Experience in auditing is desired but not mandatory
  • Previous QA experience desired but not mandatory
  • Ability to work unsupervised and independently in the production of written reports, policies and protocols
  • Excellent time management, accurate record keeping and computer literacy skills
  • Strong communication skills and the ability to work effectively with stakeholders at various levels

 

Benefits


  • Auto-enrolment pension scheme
  • Life assurance
  • Medical cash back scheme
Salary: £27,000 - £35,000
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