Europe Dossier Conformance Manager

Recruiter
RHL
Location
Tadworth
Salary
25.00 GBP Hourly
Posted
15 Sep 2017
Expires
22 Sep 2017
Contract Type
Permanent
Hours
Full Time

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.

Objective;

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.

Primary Responsibilities;

  • 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

Qualifications;

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

Rate: GBP25/hr

Please apply to Rob Francis, Resourcer/Consultant; ;

RHL is a specialist Recruitment Consultancy within Life Science talent acquisition.

Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency.