Fusion Group
Senior Quality Assurance Officer
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Senior Quality Assurance Officer
Location: Willington, UK (Hybrid)
Employment Type: Full-Time, Permanent
Who Are We?
Our client is a specialist pharmaceutical services business operating at the heart of the clinical trials industry, focusing on comparator sourcing to support clinical trial delivery. They work with pharmaceutical companies, biotechs, and CROs globally, helping them access the drug products they need to run their trials efficiently and compliantly. With an ambitious growth trajectory and a team that has already exceeded its commercial targets for the year, this is a genuinely exciting time to be joining the business.
The Role
We're looking for a Senior Quality Assurance Officer to support the implementation and maintenance of the company's Quality Management System, in relation to the importation, storage, and distribution of pharmaceutical products supporting Clinical Trial Supply. Reporting into the QA Manager and Responsible Person, this is a hands-on quality role at the heart of a fast-growing operation.
This role is ideal for someone with a strong GDP background who thrives in a busy, commercially focused environment and is looking to take real ownership of quality assurance processes.
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What Will the Role Entail?
- Supporting CTS business set up meetings and providing quality input to new programmes and initiatives
- Pre-approving and approving company transactions ensuring compliance with relevant jurisdictions including MHRA, FDA, and EMA
- Supporting collation of documentation for RPi release for products imported into the UK
- Creating, reviewing, and approving quality statements, pedigree statements, and declarations
- Creating and maintaining SOPs, work instructions, and controlled documents
- Assisting with preparation, hosting, and managing client, customer, and competent authority audits and inspections
- Maintaining QA lists including Approved Supplier List, Approved Vendor List, and Client and Delivery Site List
- Creating and reviewing Technical and Quality Agreements
- Acting on recall notifications and coordinating prompt responses
- Managing the Quality Management System including non-conformances, complaints, CAPAs, change controls, and controlled documents
- Driving Quality System records to completion through effective metrics and trend analysis
- Performing internal audits and self-inspections, and external supplier/vendor audits
- Providing training and support across functional groups within the business
- Acting as deputy QA Manager when required
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What Will You Need to Succeed?
- Demonstrable experience in a similar QA role covering GDP requirements
- Working knowledge of Good Distribution Practice and MHRA licence requirements
- Good understanding of the pharmaceutical industry
- Knowledge of products and processes used in the distribution and supply of medicines for clinical trials
- Good documentation practices and data integrity principles
- Credible and confident communicator at all levels
- Strong analytical and problem-solving ability
- Ability to work autonomously and make evidence-based decisions under pressure
- Strong organizational skills with good attention to detail
- Scientific degree in pharmacy, pharmaceutical sciences, chemistry, biology, or a related field
Is This the Role for You?
If you have a strong GDP and pharmaceutical distribution background and are looking for a role where you can make a real impact within a growing, specialist business - we'd love to hear from you. Please get in touch with Rosalind at Fusion Group - rosalind@fusiongroupglobal.com
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