Validation Area Specialist

Job Description
• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
• Ownership of Change Requests (CR’s) related to project validation responsibilities
• Perform compliance & technical reviews/approvals of protocols & protocol data
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation
• Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques
• Create & modify existing v...

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