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Irfa******
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Germany
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Last Update: 14.06.2019 at 11:01
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Munich, DE
Country
Germany
Category
Manufacturing
Description
Key Responsibilities
Technical interface to external suppliers Establish partnership with external suppliers with focus to ensure and improve product process capability, keep the knowledge of process up to date and maintain the product in constant state of validationSupport respective external suppliers with science- and risk-based approaches to ensure that product quality can be sustainably reproducedProduct/ technical stewardship for defined key molecules Act as SPOC to maintain the oversight and knowledge for entire manufacturing process throughout the entire commercial lifecycle at given external suppliersEnsure a proper understanding of manufacturing process and influencing factors (i.e. CQAs, CMAs and CPP) to ensure product quality and process robustness at the commercialization siteAssess impact of technical changes, assess technical feasibility and determine scope/ design of technical batches, challenge technical risk and business benefit of proposed technical changesContribute to the registration strategy and ensure alignment of (regulatory) timelines for technical changes, transfers, launches and/or major deviationsLead / support root cause investigation of product and process failures. Effectively liaise with external suppliers to initiate and lead/support product/ process remediation/ improvement activities, involving cross-functional teams and with clear interfaces to Quality, Operations, Engineering and Technical DevelopmentMaintain division and/or cross-division networks to share lessons learned and best practices related to process and technologies validationSupport Validation Lead and Experts to assess need and plan validations, assess revalidation needAbout Sandoz Minimum requirementsSandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.Benefits Of Working For SandozCompetitive salaryPerformance based annual bonusWork/life integrationEligible to Sandoz pension plan30 working days' holiday per calendar yearSubsidised on-site cafeteriaFree shuttle bus between Sandoz and Holzkirchen train stationAdditional benefits‘I came for the job, I stay for the culture’The ideal candidate will haveBSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent scientific Degree, ideally MSc. or PhDMinimum of 5 years of experience in Pharmaceutical/ solids manufacturingExperience in a global/matrix environmentComprehensive know-how in pharmaceutical technologySolid experience in project management and/or drug developmentSound experience of data handling and applied statisticsFluent in English, 2nd language is a plus