Project Manager in Analytical Development & CMC - France
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- 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
- 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
- Education: Master or higher degree in Science related fields
- Experience: Minimum 3 years of work experience in quality control or analytical development
- 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
- 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