CAPAs / Deviations Specialist
Company: Katalyst Healthcares & Life Sciences
Posted on: January 26, 2023
- IT Validation and Qualification: Author and review technical
documents (qualification plan, qualification summary report,
standard operating procedures, protocols, specifications, etc.)
related to the qualification of the platforms /
- CAPAs/Deviations: Support the creation and processing of
quality records including Deviations, Change Control, and CAPAs,
transferring subject matter knowledge in the process, and work with
IT Quality on the investigation and actions to close the records,
- Change Control: Create change control templates for the
organization to adopt and follow, assisting in documenting and
reviewing the records within these templates. Perform Compliance
checks on IT change control records before and after to verify that
changes are executed per Biogen processes, as applicable.
- Procedures: Review and update procedures, managing and
collaborating on the procedural documentation with the required
stakeholders, as applicable.
- Periodic Reviews: Perform activities related to the periodic
review process. Address the periodic review reports.
- Support ad hoc IT qualification activities related to
operations as needed.
Keywords: Katalyst Healthcares & Life Sciences, Elizabeth , CAPAs / Deviations Specialist, Other , Warren, New Jersey
Didn't find what you're looking for? Search again!