Analytical Method Validation Manager - Pharmaceutical
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الوصف الوظيفي Analytical methods development Analytical methods validation according to ICH guidelines. Coordinate all equipment and facilities validation activities as related to plant operations. Review and approve all protocols, reports and studies as prepared and conducted for equipment and facilities validation. Perform validation assessments for all equipment and facilities related change controls. Review, revise and develop Standard Operating Procedures (SOPs) Oversee, review and approval of the site Validation Master Plan and Validation Project Plans. Support the generation of risk assessments for various equipment and facilities related validation activities. Represent validation during agency and client audits (as needed) on matters pertaining to equipment and facilities validation Coordinate and track the corrective/ preventive action follow-ups to audits for equipment and facilities related validation issues and activities. Manage resource loading and manpower requirements associated with equipment and facilities validation activities or in support of internal / external client projects. This includes managing external validation Assist with the preparation of equipment and facilities validation budget for capital projects. Prepare request for proposals for external equipment and facilities validation resources. Review bids and prepare bid award recommendations for upper management approval. Determine and coordinate the training needs of employees directly involved in the functions associated with Equipment and Facilities Validation. Assist with the development and tracking of the department budget. Periodically update the management of relevant validation activities Support other site departments with periodic reviews and collaboration on computer system validation, aseptic media simulation programs, and environmental monitoring programs. Accomplishes staff results by communicating updated organizational information, job expectations & supporting their work Plans, monitors, and appraises direct reports including performance competencies, goals & job results Coaches, counsels, and conducts disciplinary actions Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards Contributes to the overall operations and to the achievement of departmental goals Thorough understanding of Good Laboratory Practices and Good Manufacturing Practices May be required to assist in other departments المهارات تفاصيل الوظيفة https://www.bayt.com/ar/uae/jobs/analytical-method-validation-manager-pharmaceutical-3830846/ |
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