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Manufacturing Specialist
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.WE ARE HIRINGManufacturing Specialist – External Manufacturing Management Neuraxpharm is looking for people who want to make a difference and improve patients' lives within the CNS area.We want individuals who will go the extra mile and make great things happen.Being part of this team does not mean you are just working for a company, but for a causeNeuraxpharm is looking for a Manufacturing Specialist – EMM based in Sant Joan Despí, Barcelona Your mission: Evaluation and assessment of manufacturing process for Semi finished: for solids and liquid forms (including sterile products and Pharmaceutical finished products:
for solids and liquid forms (including sterile FDF).For the assigned molecules and FDF,to become the Expert with regards of the manufacturing process along the life cycle management of these FDF, that includes the management of changes into the manufacturing process, manufacturing troubleshooting, addition of new sources of API and any change that could affect to the manufacturing process (CPP and KPP), related with externals CMO's.Within the life cycle management, to define a manufacturing transfer strategy for the defined TT projects.For that, the main topics are: Manufacturing process Transfer / Validation strategy: GAP analysis of the different manufacturing processes between different CMO's for same FDF, taking into consideration Dossier paragraph per registered country Raw materials: GAP analysis for excipients between sending Unit and receiving unit & API evaluation (CQA's impact for the manufacturing process) Packaging materials:GAP analysis for packaging materials between sending Unit and receiving unit & evaluation of any improvement according ICH stability and QA data from sending unit GMP Guidelines and country requirements Change Control procedures Project Management:
timelines – costs – risk management – change management Write or approve the technical documentation of the EMM department in accordance with current quality regulations.Provide technical support and to coordinate with Tech Transfer responsible of CMO's (sending units & receiving unit), QC & QA specialist and regulatory specialist.To define actions to address any gap or difficulty faced during the activities.Project management.Your major accountabilities: Revision of Manufacturing process Validation Protocols & Reports of manufacturing process for FDF's from CMO's.Whenever required,to provide support for the Protocol & Report edition to CMO's.GAP analysis of the different manufacturing processes between different CMO's for same FDF.Raw materials GAP analysis and primary packaging materials GAP analysis.Evaluate and approve starting materials and primary packaging materials to be used for validation batches during the TT.Revision of TT Protocols & Reports as part of the corresponding TT strategy for FDF
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