CAPAs / Deviations Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Warren
Posted on: January 26, 2023

Job Description:

Responsibilities:

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• 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 / applications
  
• 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, as applicable.
  
• 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