What are the responsibilities and job description for the Validation Specialist III position at Planet Pharma?
Job 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 :
Education :
High School Diploma or Equivalent; (4 year degree strongly preferred)
