Qualified Person
Role: 3-5 days dependant on availability – Fixed Term Contract for initial 6 months
Location: Barnstaple, Devon
Salary: Negotiable
The Role:
The following activities will be performed thereby ensuring Product Quality, GMP and patient safety is maintained to an appropriate standard for the products supplied to the market and regulatory compliance commitments are met:
- Responsible for supporting the Associate Director Quality to ensure the effective day to day management/maintenance of key elements of the PQS,
- Site Change Controls
- Supporting the Product Quality Review process for BST manufactured products
- Assessment and approval of Validation/qualification activities and management of the Site Validation Master plan
- Investigation of anomalies to assess impact on product quality, identify root cause and establish CAPAs
- Maintain compliance of and introduction of new APIs, raw materials and packaging components
- Able to act as supporting host during customer, regulatory and corporate audits
- Able to provide training in all aspects of Pharmaceutical Quality System and GMP including procedural updates
- Providing support and advice during cross functional investigations/projects as required
- Generation, review and approval of validation and other technical documents
- The review and approval of master batch manufacturing / packaging records
- Able to conduct internal and external audits as appropriate
- Supporting the technical transfer new products
- Deputise for the Associate Director Quality ensuring that all services are maintained to maximise operational effectiveness and efficiency so that both regulatory and business requirements are met at all times
- Working with the other Qualified Persons to continually improve the PQS in accordance with UK/EU and corporate requirements
- To work with other departments/functions to ensure a strong QA culture throughout the business
- To perform the Qualified Person duties in accordance with UK and EU requirements
The Person:
- Member of either Royal Pharmaceutical Society, Royal Society of Biology or Royal Society of Chemistry
- Eligible to act as a Qualified person (QP) on MIA, MIA(IMP) and ManA once granted, eligible to certify batches in line with UK Statutory Instruments
- Degree in science discipline
- Detailed understanding and significant practical experience of UK and EU GMDP for human and veterinary medicines, medical devices and other product types (e.g. Cosmetics, Food supplements, etc) across multiple dosage forms
- Extensive experience of working in a Quality Assurance related role in the Pharmaceutical Industry
- Knowledge of UK and EU quality related pharmaceutical regulations, guidance and standards
- Experience of conducting quality based investigations and root cause analysis
- Experience of conducting self-inspections and external audits of contract manufacturers/packers and service providers
- Excellent communicator
- Decisive thinker able to work within agreed timescales
- Previous experience of leading/managing teams
- Experience of US pharmaceutical regulations would be an advantage
How to Apply:
If you possess the experience, passion and ability to make this role a success then we would like to hear from you. Please submit your CV and covering letter to careers@accord-healthcare.com. The closing date is 26th April 2026
About us:
Accord Healthcare Europe is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints of any European generic and biosimilars companies selling generic medicines in over 80 countries around the world. This global footprint enables us to deliver vital, affordable medicines to national health systems supporting healthcare professionals to transform patient lives worldwide. The approach of Accord is agile and inventive, always seeking to improve products and patients' access to them. Accord are driven to think differently and deliver more for the benefit of patients worldwide.
To continue our growth, we’re looking for the best and brightest technical minds and forward-thinking business professionals. Keeping our people at the heart of all we do, we offer rewarding opportunities for those looking for continued personal and professional growth, investing in training and development tailored to each individual’s focus. So, if you’re looking for an inclusive company to take your career to the next level, you’re certainly in the right place; come and join us to make it better.