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Analytical Validation Specialist III r
Portsmouth, NH Portsmouth, NH 03801 US
Job Description
Target Pay Rate: 70-83.09/hr **salary will be commensurate with experience
Job Description:
Analytical Validation specialist IV will lead validation activities including, but not limited to, software updates, new system introduction, and decommissioning of analytical systems. This person will work closely with other functional groups like Manufacturing, Operations Technology, Computer System Validation, Engineering, and Quality Assurance to support updates to help the site remain in compliance and contribute to quality, on-time delivery and right first time performance.
Responsibilties:
• Provide Subject Matter Expert support to Quality Control, Manufacturing and other departments for the design, operation and troubleshooting of analytical equipment.
• Drive/own the validation plans and execution of analytical equipment changes and process improvements.
• Execution of Installation Qualifications/Operational Qualifications and drafting Performance Qualifications as required.
• Own all forms of TW records including CC/CAPA/Deviations to support project completion.
• Generating User Requirements Specification Documentation, complete Electronic Records/Electronic Signatures, Data Integrity Risk Assessments and Audit Trail Risk Assessments.
• Review analytical equipment, manuals, and devise validation plans
• Procurement of Analytical Equipment which includes ensuring system meets specifications, quotes, budgets and installations.
• Analytical Equipment Ownership
• Identify Quality Issues, involve stakeholders, drive to completion/resolution
• Participate on Risk Assessments
• Review/Approve Commissioning Qualification Validation Documents
• Perform other duties as assigned.
Education:
Bachelor's degree - Science related discipline or relevant experience in the field
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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