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Master Batch Record & Bom Technician

LOCATION:
Italy - Ferentino

JOB DESCRIPTION

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
  • 2 years in a similar role

 

Degrees of interest: Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering or equivalent.

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