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Laboratory Solutions Recruitment Ltd
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Basildon, Essex
Pharmaceutical Technical Transfer Manager
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Job Type: Full-time |
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Salary: £30,000 per annum |
Overview
Laboratory Solutions are recruiting on behalf of an established pharmaceutical company based in Essex and due to their Global technical transfer projects to CMO's across the world they are looking to recruit an experienced Technical Transfer Manager and a Junior Technical transfer manager role(oral dosage experience desirable). KEY TASKS & RESPONSIBILITIES: Develop Project Plans, in conjunction with other relevant parties, in relation to product site transfers or new product development projects, to include timescales, costs and identifiable risks Manage and implement agreed project plans in accordance with the product licences and GMP Guidelines Ensure that issues are identified within the project are resolved, timelines are met and where necessary, appropriate data generated Report issues / deviations from plan, costs, strategies timings and progress Generate, negotiate and see through to approval the Quality and Technical Agreements between my client and its partner Contract Manufacturing Organisation Generation, review and technically approval of Technical documentation including but not restricted to Protocols, Manufacturing and Packaging Batch Manufacturing Records, Validation Reports Ensure compliance in Technology Transfer and Process Changes with EU GMP under the supervision of a nominated Qualified Person (QP) Resolve Technical and Quality issues including unforeseen deviations relating to the production and testing of products by Contract Manufacturers and Testing Laboratories. Report issues to the QP who is responsible for releasing these products to the market Maintain up to date knowledge of Regulatory and Quality Management requirements, as needed to support the contract manufacture of current products and the introduction of new products Work with Regulatory, as part of a multidisciplinary team, regarding new and existing licence applications or variations Assist in sourcing alternative API suppliers and secondary manufacturers Assist when required, in technical Due Diligence and support in relation to the acquisition of new products, licences and / or dossiers This is a medium sized pharma company so you will have great career progression, be exposed to more of the working environment than you might be working for a large global pharma. Competive package, yearly bonus, international travel, if you are interested then please apply today