Validation Supervisor

Company: Akorn, Inc
Location: Decatur
Posted on: January 13, 2022

Job Description:

SUMMARYMaintains and coordinates the Validation Master Plan. Assists in the development, review, execution and closure of validation protocols (FAT, IQ, OQ, PQ, VQ) by collection of raw data used as supporting documentation. Assists the Manager in the scheduling and coordination of staff to meet aggressive project timelines. Provide management oversight for the Validation efforts at Akorn, Decatur. Work towards improving validation practices and procedures; ensure site compliance with current FDA regulatory requirements. This individual must be detail-oriented and compliance-minded with an understanding of cGMP, and other FDA Guidance Documents. This individual must have the expertise to interface with all levels of management, staff and internal departments, including outside contractors and vendors as applicable. They must be able to multitask within a high-stress environment to maintain critical timelines. ESSENTIAL FUNCTIONS

• Maintain and implement the Validation Master Plan along with a periodic progress report to the Validation Manager.
• Supervise personnel on projects being performed.
• Develop and write Standard Operating Procedures for the Validation Department.
• Coordinate training of the Validation staff.
• Able to troubleshoot validation equipment problems and validation issues in consultation with subject matter experts and management.
• Develop, execute, and summarize various qualification protocols for critical equipment, processes and systems for review by management.
• Review data generated in protocols and write reports summarizing results for protocol final approval by validation and other appropriate management personnel. ADDITIONAL RESPONSIBILITIESCoordinate training of new employees of the Validation Department. Additional responsibilities as required. The job may require travel to vendor sites and/or R&D facilities to complete required work. Expected travel of less than 10%.

Keywords: Akorn, Inc, Decatur , Validation Supervisor, Other , Decatur, Illinois