Key responsibilities for this role include:Dealing with Viatris Affiliates and/or Third Partner Companies to support exhibit and registration batches, through review and implementation of controls and additional requirements if needed such as manufacturing investigations. Ensuring that the Combination Product meets any requirements for reliability, through implementation of appropriate controls and assessment of the product against suitable specifications. Responsible for compilation and review of technical documentation within GDD in line with global regulatory requirements, guidance’s and the latest regulatory and industry thinking. Support of all R&D Lab activities including, Equipment calibration and Qualification, Documentation requirements, Trackwise records.Attending EHS training and maintaining responsibility for adhering to appropriate EHS procedures. Ensure the appropriate risk assessments are in place to perform required tasks. Support equipment qualifications, vendor calibrations and preventative maintenance in line with the laboratory qualification and preventative maintenance schedule as required.The minimum qualifications for this role are: Proven experience in pharmaceutical and/or medical device developmentExperience in the development and validation of analytical methods Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485 would be an advantage Experience of writing and supporting regulatory submissions would be an advantage Highly driven and motivated person who can work as part of a flexible, dynamic team whilst taking responsibility for individual tasks Well-developed communication skills to lead or facilitate effective discussions. Able to communicate technical and/or project information to key stakeholders.Some travel will be required as part of this role.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. Viatris est une entreprise mondiale de services de santé créée en 2020 par la combinaison de Mylan et Upjohn, une division héritée de Pfizer. En intégrant les atouts de ces deux entreprises, y compris notre main-d’œuvre mondiale d’environ 45 000 personnes, nous visons à offrir un accès accru à des médicaments abordables et de qualité pour les patients du monde entier, indépendamment de la géographie ou des circonstances. Nous croyons aux services de santé comme ils devraient l’être, permettant aux personnes du monde entier de vivre plus sainement à chaque étape de la vie. Et parce que nous croyons fermement qu’un meilleur accès aux soins conduit à une meilleure santé, nous réunissons des compétences scientifiques et logistiques d’excellence, ainsi que des expertises commerciales éprouvées pour fournir des médicaments de qualité aux patients, où et quand ils en ont besoin.
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