Junior Validation Engineer
CurrentResponsible for draft and completion of qualification documents, e.g. HRR, URS, SIA, SOP, IQ, OQ, PQ and qualification reports. Responsible for setting up test instruments as per requirements from SOPs and qualification protocols.Responsible for drafting qualification deviation (QDV). Experienced in identifying root-cause (5-Whys and 6-M Methods), assessing QDV impact with SMEs, and developing effective CAPAs. Coordinate qualification activities execution with… Show more Responsible for draft and completion of qualification documents, e.g. HRR, URS, SIA, SOP, IQ, OQ, PQ and qualification reports. Responsible for setting up test instruments as per requirements from SOPs and qualification protocols.Responsible for drafting qualification deviation (QDV). Experienced in identifying root-cause (5-Whys and 6-M Methods), assessing QDV impact with SMEs, and developing effective CAPAs. Coordinate qualification activities execution with operators and system owners, monitor its progress to ensure continuous compliance to cGMP requirements.Certified to operate multiple temperature/pressure/humidity data loggers system (Ellab, TMI-Orion, Eupry, KAYE Validator AVS.Excellent in IT knowledge (MS Office, Maximo and ABB DCS).Experienced in qualification of following equipment and processes:- Data Logger Systems.- Controlled Temperature Unit (CTU), e.g., cold rooms and warehouses.- Autoclaves.- WFI Break Tanks.- SIP recipes.- CIP recipes.- Media and Buffer (MBS) preparation recipes. Show less
