Company: Akorn, Inc
Posted on: January 13, 2022
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
- Coordinate training of the Validation staff.
- Able to troubleshoot validation equipment problems and
validation issues in consultation with subject matter experts and
- Develop, execute, and summarize various qualification protocols
for critical equipment, processes and systems for review by
- 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
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