Master Batch Record and BOM Technician

Settore: / Engineering /
Azienda: Randstad Italia Spa
Data annuncio: 25/01/2022
Sede di lavoro: Frosinone
Functieomschrijving

Randstad Hr Solutions, for an important pharmaceutical company is looking for a 


 


                                         Master Batch Record and BOM Technician


based in Ferentino(FR)


 


 

Responsabilità

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;


- Personnel training, checking of correct applications of GMP and operating procedures;


- Full cooperation in the different phases of the projects implementation and validation;


- Implementation of CAPAs in the MBRs;


- Involvement in 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;


- Collaboration with the whole QO, Technology Transfer, Engineering and Equipment Validation,Supply chain, Production Dept


- Management of changes in secondary packaging materials in collaboration with logistics and PCK development;


- Involvement in training courses

Functie-eisen

Knowledge, Skills, Abilities


- 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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