Main Responsabilities

• Creation and revision of Master Batch Records (for all the steps from solution preparation until packaging activities) in order to ensure cGMP compliance with EMA and US FDA requirements;
• Training of personnel checking of correct applications of GMP and operating procedures;
• Full cooperation in the different phases of the projects implementation and validation;
• Revision of procedure in collaboration with Quality Production Specialist team;
• Revision of deviation&investigation&compliant reports in collaboration with Production Deviation&Quality Operation team in order to individuate the right corrective actions;
• Implementation of CAPAs in the MBRs;
• Involvement in the technical meeting with the clients for the introduction of the new process/products in our sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting in situ;
• Management of the change control from the opening until the closing;
• Active participation in internal audits, client audit/Regulatory inspections;
• Management of the client’s requests about production processes;
• Continued collaboration with operators/Supervisors/Production Department Heads;
• Collaboration with the whole QA/QC, Technology Transfer, Engineering&Equipment Validation, Supply chain;
• Management of changes in secondary packaging materials in collaboration with logistics e QA PCK development;
• Involvement in training courses.
  

  Requirements
  

• Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering or equivalent.
• GMP, Pharma background, manufacturing of sterile products.
• Outlook Package Knowledge
• Fluent English