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Analytical Validation Specialist III
Portsmouth, NH Portsmouth, NH 03801 US
Job Description
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:
• 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
Education:
High School Diploma or Equivalent; (4 year degree strongly preferred)
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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