Check with seller Equipment Validation Supervisor

  • Location: Washington, United States


- Rockville, MD

As an Equipment Validation Supervisor, you will be responsible for oversight of all components of the Validation Lifecycle. You will also comply with all Safety, Food & Drug Administration (FDA) quality regulations and local / corporate policies and procedures.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

Provide leadership and technical support for the validation group
Establish project timelines and expectations, ensuring compliance to validated parameters
Providing technical consultation to area supervisors as it relates to quality, safety, and environmental requirements, and appropriately investing in new technologies to ensure continued compliance.
Work with Validation Managers to define, recommend, and justify validation budgets, capacity, personnel, and capital equipment needs.
Interface with management personnel in Engineering, Manufacturing, Regulatory Affairs, etc.
Participating in implementation of Validation policies and procedures.
Provide leadership and technical decision-making regarding cGMP compliance, regulatory issues, validation strategy, and quality systems.
Prepare and present technical investigative reports.
Evaluate, select and coordinate contract assistance in generating validation protocols and reports.
Lead cGMP training programs related to facility and equipment.
Support Validation Manager and Director by interacting with regulatory authorities during Site inspections relative to facility and equipment cGMP areas; supports successful management of inspections.
Ensures Self Inspection procedures for area of responsibility are in place and in use. Participate in a sampling of Self Inspections for the area(s) of responsibility.
Perform other functions as necessary or as assigned.

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