Junior Validation Engineer
Current- Assist with Process Validation for the following areas:Encapsulation machines and Blister packing lines (blister pack, foil wrap, serialization, collating), Powder Filling lines (filler, capper), Powder Packing lines (labeling, cartoner, serialization, collating), tablet compression machines and tablet coating machines, Bulk packing lines (tablets, capsules) and blending (Gallay Blender, Y-Cone Blender)- Responsable for Environmental Monitoring, temperature/RH monitoring of process facility (QBMS, BMS), microbial and air particle monitoring of process facility, temperature/RH mapping of Warehouse, stability chambers and fridges- Responsable for monitoring and control of all external and internal calibration on site. Review and site approval of calibration certificates.- Assist with generation, execution of validation protocols, reports and update (SOP’s, IQ, OQ, PQ, QR, CCF’s, etc)- Assist in carrying out internal and external audits where necessary in relation to preparing for audits, corrective actions and audit close out.- Assist with equipment qualification and review of current equipments- Assist with Data Integrity requirements for all computerised systems across all the laboratoryTechnical support of Antares, Romaco, Laetus, QBMS, BMS, Noak N950, Bosch 1400/3005, Metter Toledo terminals and scales