Summary: The Validation Senior Manager will work with other departments to make sure the risk assessment, IQ, OQ and PQ activities associated with new components, equipment (including laboratory testing equipment), systems, and utilities are performed according to established schedules, user requirements and needs. This position is also responsible for managing the activities of the Validation Department during facility shutdown activities and ensuring the plant is in a ready state to manufacture
Essential Duties and Responsibilities:
• Responsible for providing leadership to the employees within the Validation Department. Performs duties of a manager such as developing annual goals and objectives for department, developing, implementing and managing annual operating budget, approving expenditures, monitoring staffing, addressing employment issues, ensuring compliance with regulations and policies, and managing the overall functions of the Validation Department.
• Reviews and approves Validation Master Plans related to cleaning, facilities, packaging systems, and computer-related systems for the facility.
• Reviews and approves qualification, validation, re-qualification, and re-validation documents for equipment and systems, as well as manufacturing process protocols and final reports.
• Provides validation assessments for facility, utility, and equipment changes as well as input related to product technology transfers to the facility.
• Coordinates validation activities with section supervisors to ensure timeliness with minimal disruption to production schedules.
• Serves as the Validation liaison between the site and customers or regulatory agencies during facility audits/inspections.
• Develops and supports departmental strategic goals to assure the highest quality standards and regulatory compliance.
• Ensures records, and procedures are in compliance with current Good Manufacturing Practices (cGMP).
Directly supervises six employees in the Validations Department. Carries out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
Education and/or Experience:
Bachelor’s Degree in Engineering, Life Sciences or Computer Science with 6+ years of experience in pharmaceutical validation (aseptic/sterile product facility), or equivalent experience. BS degree in a scientific discipline with at least 6 years of experience, or MS degree with at least 4 years of related experience.
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