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Technology Transfer Lead For Sterile Products.Ref: mc 23528

Salary:£4058 - £5058 per annum

Added:08 Aug 2018

Region: Europe

Sector: Pharmaceutical

Sub Sector: Regulatory Affairs

An excellent opportunity has arisen to join a leading pharmaceutical company as a Technology Transfer Lead For Sterile Products. Important: Project management experience and technical understanding of Sterile Production Processes. Job Purpose: Responsible for technology transfer activities at site level). Leads technical transfer project team at site and liaises efficiently with involved functions (e.g. Development, Supply Chain, Production Unit, Quality Control, HSE, other sites. Major Accountabilities: - Manages technical activities on site level for product transfers (Process, technology, analytics, capacity, resources) - provides technical expertise - Defines and monitors project scope, timing and progress - Writes Manufacturing Process Transfer Documents (protocol, reports) - Coordinates feasibility, regulatory and validation batches at site - Supports continuous process and quality improvements - Ensures inspection (PAI: Pre-Approval Inspection) readiness - Initiates monitoring and CPV (continued process validation) phase - 80% working time would be also ok if everything else is fine Background (Musts) - Minimum BSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent - 5+ years of relevant experience in pharmaceutical manufacturing -project management skills and experience is a must - Team Lead experience - comprehensive knowledge in pharmaceutical technology - deep knowledge in cGMP, HSE, Regulatory, etc. - project management experience - of competitive nature - exercises good judgment - used to make decisions - fluent in English - German desirable

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