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
  • Segnala questo annuncio

    Thank you for reporting this job!

    Your feedback will help us improve the quality of our services.

    Invia candidatura
    La mia Email
    Cliccando su “Continua”, autorizzo neuvoo ad utilizzare i miei dati ed inviarmi avvisi email come menzionato nella sezione Politica sulla Privacy di neuvoo. Posso ritirare il mio consenso e cancellare la registrazione in qualsiasi momento.
    Modulo di candidatura