BrightOwl Loader Loading

Project Manager in Analytical Development & CMC - France  

Company managed [?] Still accepting applications

Posted on : 26 February 2017

Project Description


Description:
  • Our company is the European industry-leading specialist service provider for the Life Sciences industry, focused on delivering high quality professional services in the areas of Regulatory, Safety, Quality, Process alignment and Medical services. 
  • All our company services are targeting support for comprehensive compliance and safety throughout the product life cycle, therefore enabling continuity and productivity of product development and subsequent processes. 
  • As a result of the deployment of a new project we are now seeking a Project manager in analytical development and CMC   


Primary Responsibilities  
  • Ensure the updates / validations / transfers of the analytical methods for the control of pharmaceuticals products 
  • Participate to the stability studies with partners and subcontractors (evaluation of results …) 
  • Manage and lead the subcontracted activities 
  • Ensure the evaluation of regulatory documents for the maintenance of AMM 
  • Participation in the writing of variations (Modules 2 and 3 of the CTD) 
  • Management of responses to health authorities 
  • Audits of AMM dossiers. 
  • Technical and analytical support to the departments teams 
  • Participate in the creation, review and maintenance of the quality documentation  
  

Candidate profile
  • Education:  Master or higher degree in Science related fields 
  • Experience: Minimum 3 years of work experience in quality control or analytical development  
  

Key skills 
  • Mastery of standards (ICH, EMA, European Pharmacopoeia), as well as GMP rules 
  • Regulatory knowledge (writing variation, CMC, ICH Guidelines, GMP) 
  • Knowledge of the pharmaceutical development (formulation and/or analytical development) 
  • Knowledge of analytical techniques and / or manufacturing processes  
  

Core competences 
  • Mastery of office tools 
  • Management of priorities and organizational skills 
  • Develop positive contacts with the working environment 
  • Search permanently to optimize knowledge and skills 
  • Continuously seek to optimize knowledge and skills 
  • You are fluent in English and French (spoken and written) for daily contacts with local and internationally partners.  
  • Full training will be provided, and we encourage our staff to attend external courses as appropriate and to join professional organisations. 
  • There will be opportunities for advancement within the company or the wider group for motivated candidates, who have the ambition and potential for growth in our dynamic and international organisation. 
 

Benefits 
  • Competitive salary package 
  • Training and development 
  • International and growing company 
  • Dynamic environment