Interview : Phone and skype Visa : All apart from the ones that have employer name mentioned on the visa copy
Candidates must be willing to be on site in Chattanooga TN now. This facility is open
Description:This position requires strong experience in Pharma/FDA regulated environments, and strong communication skills.
GxP Systems Evaluator Functional Requirements:- Understand the company's SOP's, processes and policies related to cGxP Systems Compliance.
- Create an inventory of all cGxP Systems in line with the applicable SOP's.
- Conduct and document the various Gap Assessments in relation to the cGxP Systems specified in the inventory.
- Review the Gap Assessments with IT and Quality management teams and make any corrections as applicable.
- Create an implementation plan for remediation actions based on the final gap assessment document.
Academics & Soft Skills:- Deep understanding of CSV guidelines such as 21 CFR Part 11 issued by regulatory agencies such as FDA, MHRA and standards such as GAMP.
- Minimum 8-10 years of experience in Systems Administration and/or Validation of cGxP Computerized Systems, Analytical Lab Instruments and Shop-floor Machines in a FDA regulated industry.
- Thorough understanding of technical aspects such as data integrity, backup & recovery, audit trail, archival and data governance standards.
- Excellent skills at building and managing relationships at all levels of management.
- Good written and oral communication skills with ability to work in a global, multi-cultural and multi-lingual organization.