What are the responsibilities and job description for the Validation Specialist IV position at TalentBurst?
Job Title : Analytical Validation specialist IV
Location : Portsmouth, NH
Duration : 10 Months
Job Description : Summary
nalytical 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.
Key Accountabilities :
- 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.
- nalytical 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.
Qualifications
Bachelor of Science - Science related discipline or relevant experience in the field
Work Experience
dvanced - 5-10 years
Responsibilities
Quality : Adherence to cGMP is required at all times during the manufacture and release of APIs. All personnel own the quality of what they deliver and are responsible for notifying management in a timely manner of regulatory inspections, serious GMP deficiencies, process deviations, product defects and relevant actions.
Safety : Must know and follow job safety procedures, attend required health and safety training, proactively promote safety at work, and promptly report actual and potential accidents and injuries. Must comply with safety policies of the company and site. Employee owns their own safety, the safety of their team and the safety of others.
Skills :
Travel : TB_EN
