CMC Documentation Manager (f/m/d)

Good jobs with fair wages are rare, you say? Well, today is your lucky day! Our subsidiary Randstad professional solutions has a vacant position as CMC Documentation Manager in the Rhine-Main area . Tariff-based wages, care by a company medical center, and employee discounts - all advantages that you can count on with Randstad. It's best to apply online right away and secure this job! Applications from individuals with disabilities are warmly welcome.

• Prepare the respective quality CMC documentation in close collaboration with regulatory affairs, local CMC contacts or subject matter experts (e.g. quality control, production, etc.)
• On-time delivery of documents and contents aligned with RA CMC processes and templates for existing global pharmaceutical products (i.e. tech documents required for variations, geographical extensions and renewals)
• Manage the requests and activities together with ad-hoc external support

• Master's degree or equivalent with major focus on pharmaceutics, chemistry or other natural sciences
• Several years of industry experience in either pharmaceutical development or production, chemical development, analytical sciences, quality control, quality assurance or regulatory affairs 
• Profound knowledge of worldwide GMP guidelines and preferably regulatory guidelines with regards to CMC
• Skills in CMC technical writing
• Proven operational experience in preparation and review of analytical and manufacturing documentation regarding scientific issues
• Excellent written and spoken English skills
• Ability to work independently in international/multi-disciplinary project teams and to decide, prioritize and consolidate multiple tasks and complex issues
• Autonomous, analytical and organized working style

• Performance-based salary package depending on qualifications and professional experience
• Extensive social benefits, incl. Christmas and holiday bonuses
• Up to 30 days vacation per year
• Option of permanent employment with our business partner
• Definition of career goals
• A wide range of employee benefits/perks