Cqv Manager
CurrentCQV project management, starting from technical analysis up to the technical and commercial bid writing. Project budget and progress monitoring (using project Gantt), instrumental and staff management (assigned and/or required). Coordination of different streem and dealing with the related stakeholder. Management of the project activities from the kick off meeting up to the final product deliverable. Focus on the performance improvement, especially the development and implementation of new staff training and SOP learning and development.-Over than 10 years of experience in the pharmaceutical market with experience in commissioning/start-up, qualification of equipment, utilities, and validation of manufacturing processes and computerized systems.-Wide knowledge of U.S. cGMP (21 CFR Part 210-211), European cGMP (Eudralex Volume 4 and annexes), 21 CFR Part 11, EU Annex 11, ALCOA+ data integrity principles, GAMP 5, and key FDA industry guidelines.-Knowledge of pharmaceutical processes, environments and best practices.-Experience with qualification of different pharmaceutical manufacturing equipment and process vendors.-Experience developing and reviewing Validation Plan, Project Gantt and Process Risk Assessment using FMEA.- Broad and tailored analysis of equipment and systems dedicated to the production of liquid and injectable drugs.-Preparation and review of validation documents, field execution of validation and formalization activities.-Qualification and validation of HVAC systems - validation of water treatment systems (Black&Process Utilities) , pure steam, compounding, preparation, storage, transfer, filling and packaging lines.-Reading and understanding of P&IDs, layouts, wiring diagrams, functional and hardware specifications, isometric sketches.-Definition and selection of potential process instruments (according to classified areas and with the regulatory, e.g., ATEX) by correlation of media piping code and according to ASME BPE.
