Validation Manager

Basic Function : The primary responsibility of this role is to maintain the validated status of the Manufacturing Plant.

This includes direct management of validation activities related to critical aspects such as facilities, utility systems, computerized systems, equipment, cleaning methods, and manufacturing processes.

The role involves conceptualization, organization, planning, direction, and coordination with the validation and steering committee members.

Additionally, the position requires the training of plant personnel on validation concepts and strategies to ensure compliance and efficiency in validation processes.Duties and Responsibilities : A.

Work Performed : The Validation Manager is responsible for preparing protocols for validation projects, coordinating activities at all levels, and ensuring compliance with protocols, SOPs, and cGMP.

They track project progress, collect and analyze validation data, and prepare comprehensive validation reports.

The manager also recommends improvements in manufacturing processes based on validation outcomes and performs contingent tasks such as preparing deviation reports and technical presentations.

Similarly, the Validation Staff Technologist and Validation Technician prepare protocols, supervise validation activities, and ensure compliance with standards and schedules, while maintaining validation databases and performing other assigned tasks.Duties Personally Performed : The individual in this role is responsible for the validated state of the manufacturing site, preparing and controlling various Validation Master Plans, and ensuring all validation and re-validation activities meet deadlines and commitments.

They oversee the creation of Validation Teams for different projects, ensure compliance with protocols, analyze test results, and recommend necessary changes.

They also coordinate validation activities, identify training needs, and align validation activities with audit findings to enhance quality.

For computer systems validation, they work with the IT Manager to ensure proper validation and compliance with international standards.Supervision Received : The individual reports to the Quality Assurance Division Manager and operates with minimal supervision.

The workload is determined by client, regulatory, and internal validation requirements as outlined in the Site Validation Master Plan.

Functional assistance is available from department and division managers when needed, ensuring that the role functions effectively even with minimal direct oversight.Responsibility and Authority : In terms of operations, the individual is primarily responsible for the validated status of the manufacturing plant and manages validation aspects including facilities, utility systems, computerized systems, equipment, cleaning methods, and manufacturing processes.

They provide overall planning, direction, and coordination with validation committees.

They also handle office and production supplies, substantiating purchase requisitions for validation equipment, ensuring the proper use of validation department instruments, safeguarding confidential information, and maintaining departmental operating expenses within budget.

Additionally, they correspond with clients, consultants, and internal departments to manage validation matters effectively.

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