CSV Lead

Contract

CSV Lead

Woburn, MA

Required Skills / Job Description:

Job Description

The role is to lead and manage the CSV requirements for the laboratory applications and Benchtop equipment which includes software applications like Labvantage, CMMS, EDR, JMP (Statical Software) and Kinaxis.

Below are the overall Responsibilities (all these may not be applicable for all the systems). We generally expect the lead to be strategic leader and program manager for the lab area.

• Create a validation plan using a risk-based approach.
• Create a validation report that verifies compliance to the plan.
• Review requirements specification for compliance with the applicable regulatory requirements and that they are unambiguous and testable.
• Review executed operational, performance qualification documents for verifying that the testing effort has been completed, defects captured, objective evidence attached.
• Write, review, evaluate the configuration management plans and procedures associated with the development process.
• Verify that requirements can be traced through design, code, and test phases as applicable, creating Traceability Matrix.
• Raising a CR with proper description, reason for change, implementation plan, impact assessment and other requirements per customer's SOP; Reviewing and verify execution of CR; Monitoring CR through closure
• Raising a deviation, processing, investigation, causal analysis, implementation, efficacy, closure, and other requirements per customer's SOP.
• Raising an IT CAPA, initiation, action processing, root cause analysis.
• Monitoring deviations and CAPAs for extension, amendment, approval, and closure.
• Conduct post-implementation; periodic review of systems.
• Dry run and execute test protocols. Review executed test scripts.
• Qualification of Manufacturing Equipment
• Backup and Restore testing support