Analytical Validation Specialist
Apply NowCompany: Ageatia Global Solutions
Location: Portsmouth, NH 03801
Description:
The Analytical Validation Specialist III role will assist validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. The individual will work closely with Senior Analytical Validation Specialists and other functional groups to contribute to quality, and right first time performance. This role requires closer support from other Subject Matter Experts and Management.
Develop Technical Knowledge and documentation on analytical equipment.
Provide Subject Matter Expert support for troubleshooting of analytical equipment.
Assist and support the planning and execution of validation plans involving analytical equipment changes.
Perform advanced troubleshooting and advanced helpdesk tickets (template creations, focus control etc.)
Execution of Installation Qualifications/Operational Qualifications and Performance Qualifications.
Own change requests and complete change request tasks to support project completion
Assist in Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
Review analytical equipment, manuals, and help devise validation plans
Identify Quality Issues, involve stakeholders, help drive to completion/resolution
Assist in completion of Correct Actions/Preventative Actions
Review/Approve Commissioning Qualification Validation Documents
System Acceptance Ownership and Completion
Vendor escorting as needed
Demonstrates ownership and remediation of Data Integrity
Skills:
Good working knowledge on Validation deliverables and Data Integrity principles.
Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
Demonstrate sound decision making.
Ability to work inter-departmentally and with customers.
Demonstrates role model behaviors for GMP and Safety behaviors
Strong written and verbal communication skills
Ability to work in MS Project, Word, Excel, PowerPoint
Develop Technical Knowledge and documentation on analytical equipment.
Provide Subject Matter Expert support for troubleshooting of analytical equipment.
Assist and support the planning and execution of validation plans involving analytical equipment changes.
Perform advanced troubleshooting and advanced helpdesk tickets (template creations, focus control etc.)
Execution of Installation Qualifications/Operational Qualifications and Performance Qualifications.
Own change requests and complete change request tasks to support project completion
Assist in Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
Review analytical equipment, manuals, and help devise validation plans
Identify Quality Issues, involve stakeholders, help drive to completion/resolution
Assist in completion of Correct Actions/Preventative Actions
Review/Approve Commissioning Qualification Validation Documents
System Acceptance Ownership and Completion
Vendor escorting as needed
Demonstrates ownership and remediation of Data Integrity
Skills:
Good working knowledge on Validation deliverables and Data Integrity principles.
Working knowledge and experience with Quality Systems including deviations, change controls, CAPAs, OTNs, deviations; both the system (TrackWise) and the practical applications in operations
Knowledgeable in process, equipment, cleaning, and computer system validations to the extent of being able to effectively review and approve protocols and reports and support implementation of new equipment.
Demonstrate sound decision making.
Ability to work inter-departmentally and with customers.
Demonstrates role model behaviors for GMP and Safety behaviors
Strong written and verbal communication skills
Ability to work in MS Project, Word, Excel, PowerPoint