Job Title: Validation Specialist IV
Location: Portsmouth, NH
Duration: 01 Year contract with possibility to extend
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.
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
Skills:
Advanced technical knowledge of Quality control and manufacturing operations.
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.
Demonstrated ability to manage medium to large sized projects within required timeframes.
Demonstrate ability for effective Planning, Organizing and Controlling competency
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
...self-starters and those who are committed to doing what is best for our customers. Brown & Brown is seeking a Student Summer Intern to join our growing team in Maitland, Florida! The Sales Internship provides exposure and training to all aspects of a...
...Company Description Short Hills Aviation Services is a luxury air charter service provider located at the Morristown Municipal Airport... ...associated with scheduling and coordinating flights, managing logistics, ensuring safety and compliance, and communicating effectively...
About the Company - Accounts Receivable Management Company About the Role - This individual will be responsible for collaborating with all company departments and suppliers to provide accurate and timely responses to client requests and deliverables. This position...
*****Teachers Wanted-Train as a Financial & Insurance Sales Advisor***** Are you a current or former educator looking for a meaningful new career path where you can continue to make a difference in peoples lives? Were seeking compassionate, driven individuals to...
...jointly with the Illinois Environmental Protection Agency. U.S. Department of Transportation, Charging and Fueling Infrastructure (CFI): The CFI program represents approximately $15 million in discretionary grant funding. Funds will be used for electric vehicle...