Europe Dossier Conformance Manager
A fantastic opportunity has arisen for a European Dossier Conformance Manager with a leading pharmaceuticals brand focusing on Module 3. Be part of a brilliant team looking to deliver the best in quality and compliance.
Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, you should be committed to quality and excellence in compliance and conformance. Work in close collaboration across the regulatory organisation between Global, Regional and Country teams.
- Data collection and evaluation in preparation for product and market assessment.
- Perform conformance analysis of source dossier with market dossier
- Ensure compliance systems accurately reflect market approval and manufacturing practices
- Operate to the highest conformance standards
- Operate in line with internal SOPs and policies
- Liaise with regulatory colleagues to communicate and resolve potential issues
- Ensures timely communication of any issues
Bachelor's degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences. Minimum 3 years of experience in a quality or compliance role within the pharmaceutical industry.
Good knowledge of content and requirements for CTD Module 3 Knowledge and understanding of quality systems, processes, audit and inspection Knowledge on general standards, processes and policies of Pharmaceutical manufacturing Industry
Job Title: Europe Dossier Conformance Manager
Reference No: 235917
Location: Tadworth Job Type: 12 month contract, 37.5hrs per week
Please apply to Rob Francis, Resourcer/Consultant; ;
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