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QA Officer

  1. North West
  1. Permanent
£25000 - £30000 per annum
26079
  1. Compliance / Quality Assurance
Date Posted18 Feb 2021
Our world-leading Pharmaceutical client based in the North West of the UK are looking for a QA Officer to specialise in one of three main areas within the organisation (Project Operations / Project Introduction / Project Lifecycle). This role will be an essential function within the Quality Assurance department. It will involve working closely with the Production, Laboratory, Product Development, Project Management and Business Development teams. 


Project Operations Responsibilities:
  • Performing quality assurance checks during manufacturing /packaging / labelling activities as defined in the batch document.
  • Reviewing and approving executed batch manufacturing records to ensure products have been manufactured compliantly.
  • Reviewing and approving environmental monitoring results for the GMP cleanrooms.
  • Verifying that clean room conditions were achieved during manufacturing operations.
  • Provide quality guidance during manufacturing issues, help to define batch record comments to explain events and assess the impact to the manufacturing process and the product quality.
  • Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.
  • Approving raw materials for use in clinical manufacture.
  • Reviewing and approving Standard Operating Procedures.

Project Introduction Responsibilities:
  • Reviewing and approving specifications for raw materials, IPCs, finished products, final packaging.
  • Reviewing and approving SOPs, analytical methods, stability protocols, technical reports.
  • Reviewing and approving method qualification / validation performed both internally and by external parties.
  • Reviewing and approving executed Feasibility / Engineering batch documents, the associated analytical testing and resulting technical report (to facilitate the handover into clinical manufacture).
  • Reviewing and approving master batch records (for dispensing, bulk manufacture, packing and labelling activities) and label templates.
  • Approving raw materials for use in clinical manufacture.
  • Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.

Project Lifecycle:
  • Preparation & QA review of batch dossier and product specification files to support QP release of product to clinic.
  • QA review of change controls including shelf life extensions for products in the clinic.
  • Performing quality assurance of stability data to support shelf life of product in clinic.
  • Providing Quality guidance and support in laboratory investigations, deviations, change controls, quality improvements, customer and supplier complaints, implementation of CAPA.
  • QA review of updates to finished product specifications, IPC specifications, analytical methods, SOPs and stability protocols etc.

Key Skills / Background:
  • Possess a scientific or pharmaceutical production background (degree in scientific or pharmaceutical science preferred)
  • Strong understanding of Good Manufacturing Practice and its application for both Investigational Medicinal Products and Commercial Products
  • Prior experience in Quality Assurance role.
  • Experience of working closely with manufacturing is preferred.
  • Good level of attention to detail, good organisation and interpersonal skills.
  • Confidence and ability to represent the department in project meetings.

If you are interested in learning more, please apply today.

The candidate must have the rights to work in the location stated in the job advert.

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