Master Batch Record & Bom Technician
Italy - Ferentino
- 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.
- 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
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