Job Description:
Job Description
#INDIST
Responsibilities
- Manage the Change Control process for assigned projects
- Lead cross-functional team meetings and ensure capture of discussion points and action items
- Report to the Compliance Office for the duration of all assigned projects
- Work with business managers to implement validation process and documentation
- Comply with company's Global IT Policies & Procedures
Required Experience
- 2 years of experience or more in healthcare validation process experience in large organizations
- The consultant would need CFR Part 11 compliance knowledge who can review the documents and confirm they are in line with our standards.
- Experience with Application Development related Technologies for 2+ years
- Validated Systems experience is required leading and managing IQ/OQ/PQ FDA regulatory process
