Validation Expert

Vor 5 Tagen


Aubonne VD, Waadt, Schweiz Merck KGaA, Darmstadt, Germany Vollzeit

The MSAT DP within the Fill & Finish Department leads and manages all the Drug Products site technical activities within Merck BioPharma Aubonne site to ensure the supply of New Biologic Entities (NBEs) and the business continuity and Product-Lifecycle activities on legacy products portfolio, in compliance with specifications, registration and GMP requirements. To evolve in this environment, we are looking for our next Validation Expert (m/f/d). Your role : To ensure the deployment of the Process Control Strategy on the Fill&Finish department for all manufacturing processes according to Good Manufacturing Practices and Company's Quality StandardsTo ensure the continuous reporting for monitoring activities for all manufacturing processes according to Good Manufacturing Practices and Company's Quality StandardsTo maintain all actions related to the control strategy and monitoring within the expected timelinesTo ensure site readiness for Health Authorities' inspection on Control Strategy and monitoring topics Who you are : Degree in Biotechnology, Process Engineering, Pharmacy, statistics or related subject. Good knowledge of pharmaceuticals business, of regulatory pharmaceutical guidelines (cGMP) related issues and Health Authorities requirementsGood knowledge of F&F processes/unit operationsExperience in international pharmaceutical companies with a fluency in english and frenchStrong interpersonal skills and ability to interact positively and constructively with all functions in matrix organization environment.Strong expertise in statistical analysis with a good knowledge of main analytical techniques and their application for panel testing


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