Writing batch records and cleaning records for commercial products or simple revisions, campaign reports, as needed to support production operations.
Initiate SOPs and investigations/deviation reports/CAPAs for production operations and commercial products.
Reviewing and approving documentation (batch records, cleaning records, supplements, etc.) for Operations as the area technical expert.
Troubleshoot equipment and coordinate with maintenance to monitor equipment for efficiency improvement.
Assist Process Engineers and Chemical Development teams when new processes are transferred into the area workcenter.
Work with Validation Engineering and Maintenance departments on developing and maintaining IQ, OQ and PQ documents and protocols. Ownership of equipment and facility change controls in their assigned area workcenter.
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