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Irfa******
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Germany
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Last Update: 13.06.2019 at 02:56
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Munich, DE
Country
Germany
Category
Research Positions
Description
Key ResponsibilitiesTechnical 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 need