Manufacturing Support Specialist
1 maand geleden
Proclinical is seeking a Manufacturing Support Specialist to manage and facilitate successful commercial production and ensure a stable product supply of EMEA manufactured products. This includes driving technical investigations and root cause analysis at Contract Manufacturing Organisations (CMOs). The role also involves participating in Tech Transfer Projects for both existing EMEA products and New Product Introductions (NPIs), ensuring continuity of supply for existing products and timely new launches. This position contributes to commercial product support activities including cross-functional cooperation and interactions with the CMOs.
Responsibilities:
Handle process and filter validations of the transferred manufacturing processes.Responsible for manufacturing process changes including change control management.Stay up-to-date on critical process and material details list.ssist or lead manufacturing process-related deviation evaluations in agreement with QA.You will transfer of the manufacturing method/process to the CMO, including providing manufacturing method details, product specification, and critical material information.Compile regulatory documentation on manufacturing process and primary packaging materials.Maintain information on manufacturing equipment & CMO expertise.Ensure the validity of the processes; review the ongoing process verification protocols.Contribute to the process transfers according to the Global Tech Transfer Project (GTTP) process.Key Skills and Requirements:University graduate in pharmacy/medical/life sciences.Fluency in English (oral and written).Demonstrable experience working in the Pharmaceutical and/or Medical Device industry.Experience working in a global environment.Understanding of GMP requirements and knowledge in the manufacturing of sterile products.Ability to operate and communicate both internally and externally.Experience in product support and/or technology transfers.Cross-functional and cross-cultural working ability.Self-starter, motivated and self-driven.Excellent writing, editing and computer skills including MS Office (Word, PowerPoint, Excel, Vision and, if possible, MS Project). If you are having difficulty in applying or if you have any questions, please contact Patrick Turbidy at Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. Proclinical Staffing is an equal opportunity employer.-
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