Overview
On Site
Full Time
Skills
Media
Warehouse
Pharmaceutics
HVAC
Acquisition
Technical Support
Functional Requirements
URS
Regulatory Affairs
FRS
Auditing
Inspection
Change Control
Corrective And Preventive Action
Job Details
Responsibilities:
- Perform Smoke studies and assist in semiannual Media fill qualifications as a SME
- Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers, and warehouse areas.
- Has worked with Ellabs data loggers and software.
- Write and execute protocols and complete final reports.
- Understanding of cleaning validation concepts and principles.
- Understands pharma grade utilities (water HVAC, gases).
- Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
- Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
- Develops and Assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are always "inspection ready".
- Support Change Control, Deviation and CAPA activities.
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