Quality & Regulatory Officer - Fixed Term Contract - Bedford, United Kingdom - Cast UK Limited
Description
Quality & Regulatory Officer
Fixed Term Contact
Bedford
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£35,000 Benefits
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Role Profile
Support the QA and Business Development teams with the essential regulatory and licensing information for Customer requirements
- To provide customer support with maintenance of existing licences
- To support and advise customers with new licensing and regulatory affairs
- To prepare and coordinate critical regulatory submissions
- To liaise between customers and regulatory authorities
- To write support arguments, risk assessments and reports
- Assist in the compilation and review of standard operating procedures, work instructions and other relevant documentation
- To support Quality Assurance team with internal audit activities
- Day to day running of the quality management systems and processes including, but not limited to, internal compliance audits in line with ISO 9001, ISO 13485, FEMAS, Soil Assication, HPRA, MHRA and FDA, product inspections, document control and identification, CAPAs and control of nonconforming products.
- To undertake any other such duties that from time to time may be required to maintain quality levels within the business
Skills & Experience
- Ability to function in a dynamic, contracting environment
- Excellent presentation and communication skills
- Ambitious, with the potential to contribute to a rapidly growing business.
- High level of accuracy
- Strong IT skills
Client information
Exceptional high growth international manufacturing operation based in Bedfordshire.
Remuneration
£35,000 Benefits
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