What are the responsibilities and job description for the Validation Specialist(CSV Specialist ) - Portsmouth, NH position at Unicon Pharma Inc.?
Job Title: CSV Specialist Level 3
Job Description:
Summary:
- The CSV Specialist Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance.
- The CSV Specialist Level 3 will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions.
- This position also provides guidance to junior team members.
- Specialist will be involved as the QA CSV representative during small and large-scale project
Job Description:
- Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs
- Execute all responsibilities as CSV project lead for simple projects
- Oversee/perform all CSV qualification activities for DeltaV and Syncade systems
- Perform Validation Maintenance of computerized systems
- Review/Revise CSV SOPs
- Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)
- Assist with audits and inspections
- Perform other duties as assigned
Required Skills:
- Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
- Strong written and oral communication skills