CSV Validation Approver

Location: Vizianagaram

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  GxP  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).

Qualifications:

Bachelor’s degree in Life Sciences, Pharmacy, Engineering, or a related field preferred.
2-3 years of proven experience specifically in reviewing and approving  CSV deliverables  (not just executing validations).
Strong knowledge of  GxP  regulations and experience working within  FDA  regulated environments.
Experience in the  Pharma  or  Lifescience  industries, preferably with exposure to  Medical Device  validation processes.
Familiarity with the FDA's  CSA  approach and regulatory expectations for software validation is a significant advantage.
Excellent communication and collaboration skills with the ability to work effectively in a remote, cross-functional team environment.

Tools and Technologies:
Proficiency in  JIRA  for managing validation deliverables and tracking project progress.
Strong working knowledge of  CSV Review  and  CSV Approval  processes and documentation standards.

Experience with electronic document management systems (EDMS) and validation lifecycle tools is a plus.