Job Description
Roles & Responsibilities :
- 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.