Job Description
Title - CSV Validation Approver
Type - Contract
Location - Remote
Roles and Responsibilities:
Review and approve CSV deliverables to ensure completeness, accuracy, and compliance with regulatory requirements and internal standards.
Collaborate with validation teams to provide guidance on FDA and Gx P compliance, ensuring alignment with the FDA's Computer Software Assurance (CSA) approach.
Manage and track validation documentation and activities using JIRA , ensuring timely updates and resolution of issues.
Support cross-functional teams by providing expert input on validation strategies and deliverables.
Participate in risk assessments and validation planning to uphold regulatory and quality standards.
Ensure all validation activities meet organizational policies and regulatory expectations within the Medical Device and Pharma sectors.
Facilitate communication between global teams by being available during overlapping working hours (through Noon EST/EDT).<...
Type - Contract
Location - Remote
Roles and Responsibilities:
Review and approve CSV deliverables to ensure completeness, accuracy, and compliance with regulatory requirements and internal standards.
Collaborate with validation teams to provide guidance on FDA and Gx P compliance, ensuring alignment with the FDA's Computer Software Assurance (CSA) approach.
Manage and track validation documentation and activities using JIRA , ensuring timely updates and resolution of issues.
Support cross-functional teams by providing expert input on validation strategies and deliverables.
Participate in risk assessments and validation planning to uphold regulatory and quality standards.
Ensure all validation activities meet organizational policies and regulatory expectations within the Medical Device and Pharma sectors.
Facilitate communication between global teams by being available during overlapping working hours (through Noon EST/EDT).<...