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Project Manager in Analytical Development & CMC - France  

Product Life Group (company)


Posted on : 26 February 2017

Project 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. 

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