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Irfa******
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Germany
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Last Update: 13.06.2019 at 04:16
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Stuttgart, DE
Country
Germany
Category
General Administrative
Description
Job ResponsibilitiesEstablishing robust, efficient external pharmaceutical & chemical supply chains for successful new product launches from development through to market launch.Building strategies for transferring the products to contract manufacturing organizations (CMOs) for each stage of the supply chain.Selecting suitable CMOs and constantly maintaining relationships to ensure that the scope, execution, and reporting of predefined requirements and tasks meet project plans.Defining all product specific requirements such as validation, stability, and packaging as part of product target profiles and validation master plans.Maintaining established commercial production regarding troubleshooting, deviations/complaints, changes, and regular quality reviews.Ensuring that external manufacturing meets global quality standards and applicable regulatory requirements.Compiling specific SOPs/documentation, including regulatory documents for submissions, reviewing protocols and reports for completeness, and overseeing cGMP compliance and acceptability of data.Skills And RequirementsUniversity degree from a scientific field, preferably in a pharmaceutical & chemical environment.At least 3 years' experience in pharmaceutical & chemical manufacturing (preferably in aseptic filling), with working knowledge of manufacturing processes, validation, and change control concepts.Excellent understanding of FDA, EU, and ICH cGMP guidelines, and industry best practices.Expertise in validation, qualification principles, and standards with demonstrated ability to apply these to GMP operations.Ability to solve problems, work in multi-disciplinary teams, exhibit excellent interpersonal skills and prioritize multiple tasks.Experience in the compilation of relevant procedures, protocols, reports, and regulatory submissions documents.Proven history of working with several CMOs and ability to define key selection criteria.Willingness to spend 20% of time travelling globally.Fluent in English, German is a plus.Demonstrable project management skills.Demonstrable multitasking, project management, and execution skills.Good interpersonal skills, including communication, presentation, persuasion, and influence.Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.Proficiency with computer skills, such as MS Office.