Clinigen
Quality Compliance Officer
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About Clinigen
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
We are currently 1,100 people headquartered in the UK with global offices in the US, EU, JAPAC and South Africa. Clinigen has grown rapidly since it began in 2010 and is positioned well for an exciting future of continued expansion.
Role: Quality Compliance Officer
To support growth, we are seeking a confident and proactive Quality Compliance Officer to join our Quality Assurance function within the Quality Compliance and Documents Team based in Weybridge. This role will ensure compliance functions are carried out in line with domestic license obligations. Assist in the Quality Management System for Document and Learning Management in line with relevant procedures.
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Responsibilities
- Processing of MHRA import notifications and subsequent acknowledgements, inc. objections and further information requests
- Processing HPRA exempt medicinal product notifications
- Ensure cover for all operational daily Quality Compliance duties in co-operation with colleagues.
- Creation and maintenance of Quality Compliance ERP components
- Internal and External processing of special clinical needs letters and in-house authorisations.
- Respond and support the business requests for document updates, document obsoleting and document archiving in eQMS
- Maintain the Document Processing and Document Management associated work instructions
- Keep training matrices relevant and up to date.
- Ensure employee names, roles and reporting structure is current within the LMS
- Respond and support the business requests for the creation of all courses for the SOPs & Policies from the eQMS and other Clinigen training courses
- Ensure training material is correct and current.
- Provide reports of compliance status of training records.
- Act as an LMS admin for Clinigen and provide training to local LMS admins across the Global Clinigen sites
- Maintain oversight of GxP training compliance and annual review and update of training material
- Create and maintain the process on how to report monthly training for GXP training compliance status to identify gaps and overdue training.
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Benefits
- 27 days holiday plus 8 bank holidays
- Pension contributions 4.5% matched
- Life assurance 4 x annual salary
- Flexible Benefits Platform with £25/month Company contribution
- Annual salary review
- Independent financial advice service
- Enhanced Employee Assistance Programme
- Shopping discounts with retailers
- Long service awards
- Recognition scheme & employee of the year awards
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