Validation specialist

3 days ago


Kuwait City, Al Asimah Mezzan Full time
Role & responsibilities Responsible for execution of SAT, installation, operational and performance qualification equipment's & instruments. Responsible for execution of qualification activities related to thermal validation i.e. Steam sterilizer, vessels/tank system, Lyophilizer and tunnel etc. Responsible for equipment qualification i.e. filling & sealing m/c, vial washing, external vial washing m/c, HVAC, Isolators, VHP process, LAFs & dynamic pass boxes etc. Responsible for execution of temperature mapping activity for area and equipments. Responsible for compilation of documents during and / or after execution of any qualification / validation activity. Responsible for co-ordination and planning of qualification / validation activities. Responsible for compliance of validation schedule / planner and to ensure that, equipment qualification should be completed within due date. Responsible for preparation and /or review of validation master plan and site master file. Responsible for preparation and / or review of qualification / validation protocols and reports in complies with current guide lines. Responsible for preparation of SOP relate to QA validation policy / activities. Responsible for preparation and / or review of media fill protocol. Responsible for review of media fill interventions trend data. To involve in media fill simulation activities and responsible for compilation & preparation of media fill report. To involve / participate in investigation during failure / discrepancies related to qualification / validation (if any). Responsible for review of relevant documentation, i.e. logs books, calibration records, preventive maintenance records etc. To ensure engineering assurance at site. Responsible for review of (CSV) computer system validation documents with compliance of current regulatory requirements. To update and review of periodic qualification planner / schedule. Responsible for initiation and completion of QMS documents. Responsible for completion of SOP training and CGMP training. Ensure compliance with Good Manufacturing Practices (GMP and ISO), safety policies, and good housekeeping and that safety and hazard practices are understood and implemented. To analyse and solves engineering-related problems with effective manner. To work on lean management techniques to simplify the equipment qualification / validation approach.
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