CMC Project Leader (m/w) - Freelance Nr ref.: /JOBS.pl CMC Project Leader (M/W) - FreelanceEurope€100.00 Per Hour The opportunityI am currently working with a growing Biotech who are looking for an experienced CMC Project leader on a freelance basis. These can be based anywhere in Europe, however you must be able to travel to Frankfurt for the first 2-3 weeks SOP training. The ideal candidate will possess the following; * At least 5 years experience in CMC regulatory project management. * Expertise in Quality and risk management. * Exceptional knowledge of GCP/GMP requirements for test samples. Your tasks will include: * Alignment of CMC development strategy in accordance with the overall project strategy to approval * Definition of a Quality Target Product Profiles * Identification and risk assessment of the quality attributes * Planning, review and timely supply multi-centre clinical studies on samples (Monoclonal antibody) * Project planning, monitoring and coordination of subcontractors * Ability of parent cooperation with the fields of clinical research and quality assurance and various external partners * Support for demand planning and coordination of the packaging / labelling by external partner * Creation, review and approval of label texts * Preparing the release of samples by the Qualified Person * Organization of temperature controlled transports to study centres and country-depot * Evaluation of the transport temperature and processing variations * Preparing and reviewing SOPs Your skills * Science Studies * CMC experience in the development of Biologics * At least 5 years of professional experience in production of investigational medicinal products or Prüfmusterlogistik * Expertise in project management, quality management and risk management * Excellent knowledge of GCP and / or GMP requirements for clinical test samples * Organizational skills, communication skills and independent and structured way of working * Very good English skills in speaking and writing * Professional familiarity with MS Office Employees will be offered an interesting, diverse and challenging job in a friendly atmosphere in a friendly and competent team. We work in flat hierarchies and short Decision-making processes. Applying for the jobThere are various ways to apply for this position: * Apply direct from the website () by clicking "apply now" * Contact the consultant directly:Stuart Gill- (0) About TEC Group InternationalWe are TEC Group. We are international recruitment specialists. We are the link between highly-specialised industries and the professionals that make them work. Expert consultants, a global network of offices and the latest technology allow us to join the dots in the talent process. TEC Group International supports the Scientific, Engineering and Energy sectors. We have completed assignments in over 60 countries and support projects all over the world through our subsidiaries and partners. Kontakt: Aplikuj teraz Ogłoszenie pochodzi z serwisu Jobs.pl .
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