Fixed term contract - Master Batch Record & BOM Technician
Thermo Fisher Scientific
Ferentino, Lazio, ITA
1 gg fa

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 QO, 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
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