Regulatory Compliance Executive - Hitchin, United Kingdom - Atom Recruitment Ltd.
Description
Our Client is a very successful pharmaceutical company.They are now seeking a
Regulatory Compliance Executive. This position is a full-time permanent role and will be office based near
Hitchin, Hertfordshirewith the possibility of hybrid working (3 Days Office / 2 days Home).
Job Purpose
- An opportunity has arisen for a Regulatory Compliance Executive to join the Regulatory team
- The role will provide comprehensive and broadranging expertise in all aspects of maintaining product regulatory and quality compliance
Key Areas of Responsibility
- The key responsibilities include the review and approval of all internal control documentation (e.g. raw material specifications, analytical methods, packaging specifications and production monographs), as well as managing all quality related tasks anddocuments controlled on the electronic quality management system
- It will be essential to keep aware of ongoing changes within the company to ensure internal documentation and systems are aligned with licenced details, while maintaining the document management system for licenced/registered product information
- Additionally, it will be necessary to give regulatory compliance guidance and support to other departments, particularly Pharmaceutical Development, Purchasing & Supply and Production.
- It will be important to ensure continued regulatory compliance and highlight any upcoming changes to help identify impacts on planned and existing products and associated practices / procedures.
Qualifications / Experience
- Excellent verbal and written communication skills, with the ability to present complex issues in a clear, logical, and persuasive way with confidence to defend an expert opinion is essential
- They will also need to have strong organisation and planning skills with computer competence and meticulous attention to detail
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