Coordinate all activities, within the Plant, which are part of the Plant Validation Program. This includes timely
completion of validation protocols, working with relevant departments to ensure people are aware of, and
understand, the validation process and ensuring that the Plant Validation Master Plan is implemented.
Support regulatory compliance through plant preparation for, and participation in, regulatory audits.
Enforcing and training personnel on EL’s Hygiene and Sanitization policies.
Plant lead for environmental monitoring, developing and maintaining the contamination control plan, and
trending of microbiological data for finished goods, bulk, raw materials, and water.
Active participant in the Global Microbiology Working Group, manage the site product and raw material micro
qualification program, drive continuous improvement
Lead the plant through the effective implementation of the Validation Master Plan
Complete validation protocols in a timely fashion
Work with relevant departments to ensure people are aware of, and understand, the validation process
Ensure that the plant validation master plan is implemented.
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