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