QA Officer

1 month ago

England, United Kingdom S3 Science Full time

We are thrilled to offer a new exciting opportunity working with our client who are a toxicology contract testing laboratory supporting pharmaceutical companies, vaccine researchers and manufacturers, biopharmaceutical startups and their investors as well as 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 occasional working from home.

As the company grows and the QMS develops there is a great opportunity to get involved with Quality Process design to improve existing procedures with regards to 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 portfolio of testing and analysis services.

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 as well as the policies and procedures of our internal Quality Management System (QMS).

Responsibilities

* 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

* Supporting the execution of all aspects of the QMS. This includes Change Control documentation, investigation reports associated with non-conformances, 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 to laboratory staff on Quality related issues

* Other related duties as required and/or assigned

Requirements

* Experience working within a GMP or similar regulated industry

* Knowledge of Quality Management principles, tools, and methodologies

* Experience of auditing 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 #J-18808-Ljbffr

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