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
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).
