MES Validation Consultant at Cognizant in Daytona Beach, Florida

Job Description: Detailed overview of functional and technical role expectations

Mandatory Skills:

Any MES system, preferably Rockwell FTPS

Exposure to Pharma Industry QA/validation(CSV)

Able to review of validation and change control docs like protocols, test plans, computer system validation, etc.

Understand deviations and help business fix

Understanding of 21 CRF Part 11, GAMP, etc

Job Roles/Responsibilities:

• Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.

• Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.

• Release equipment back to GMP manufacturing as part of change control.

• Have the ability to independantly assess impact and re-testing requirements in the event of a deviation.

Preferred Skills

Preferred Skills:

·         Site MES Deployment experience

·         Pharma Industry exposure to processes

Exposure to SOPs, protocols, Project Mgmt, etc