Mantell Associates is partnered with a leading Biotech organisation in their search for a Quality (Validation, Process Consultant) to support Process Performance Qualification (Process Validation) activities in accordance with Regulatory requirements.Quality (Validation, Process Consultant) - Requirements: Develop pre-validation / validation strategy, including the strategy for supportive studiesCoordinate activities between all departments involved in individual activities of drug substance manufacturing process validation and cleaning validationCreate protocols and validation reportsInitiate monitoring and continuous process verification phase and compilation of the first APQRAct as single point of contact for a given validation processContribute to the overall strategy and plans of projects scope, including the creation of schedules and budgetsDevelop validation plans, scientifically sound technical strategies (with validation team) and contingency plans, identifying obstacles and proposing possible solutionsPlanning of resource needs (full time, investment, external costs), strategies and schedulesProcess Validation Expert - Requirements: Higher education in the field: biotechnology, pharmacy or relatedStrong professional experience in the biotechnology or pharmaceutical/medical industryExperience in validation of manufacturing processes and cleaning validationExcellent knowledge of GMP, EMA and FDA requirements and current technology transfer guidelinesThe ability to organise work well and to cooperate in a teamAbility to identify and solve problems independentlyMantell Associates is a specialist Pharmaceutical and Life Sciences headhunting firm. For more information on this role, please contact us at +44 (0)20 3854 7700.
Job Title
Quality (Validation, Process Consultant)