Master Batch Record and BOM Technician

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

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


                                         Master Batch Record and BOM Technician

based in Ferentino(FR)




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


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

La ricerca è rivolta ai candidati ambosessi (L.903/77). Ti preghiamo di leggere l'informativa sulla privacy ai sensi dell'art. 13 del Regolamento (UE) 2016/679 sulla protezione dei dati (GDPR).

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