Job Description
Job Title: CSV Specialist
ID: 26-03852
Location: Portsmouth, NH, 03801
Duration: 06 Months
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.
Accountabilities:
- Specialist will be involved as the QA CSV representative during small and large-scale projects
- 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
Education:
- Bachelor's Degree required
Field of Study : Computer Science / Software Engineering (Preferred) - Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
- Strong written and oral communication skills
- Strong organizational and time management skills
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com
Numbers & Facts
| Location | Portsmouth, NH |
| Industry | Staffing/Employment Agencies |
| Company Size | 100 to 499 employees |
| Year Founded | 1990 |
| Website | http://www.sunrisesys.com/ |
About Company
Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.
We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.
Our collective business experience spans over two and a half decades and ranges from:
- Business, management, and technical fields
- Information technology consulting and software solutions.
- Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
- Motivating technology staff and establishing partnerships with Fortune 500 companies
Sunrise Systems has a vast range of competence in:
- Design, development, and support of cloud-based solutions from simple to highly complexed
- Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
- Data processing and data migration
- Application re-engineering and platform migration
- Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
Skills
- Change Controlunmatched
- Change Requests/Ordersunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Computer Scienceunmatched
- Computer Systemsunmatched
- Corporate Policiesunmatched
- DeltaVunmatched
- Documentationunmatched
- GMP (Good Manufacturing Practices)unmatched
- Maintain Complianceunmatched
- Organizational Skillsunmatched
- Presentation/Verbal Skillsunmatched
- Quality Assuranceunmatched
- Risk Analysisunmatched
- Software Engineeringunmatched
- Standard Operating Procedures (SOP)unmatched
- System Validationunmatched
- Systems Analysisunmatched
- Systems Maintenanceunmatched
- Team Lead/Managerunmatched
- Test Plan/Scheduleunmatched
- Test Scriptsunmatched
- Time Managementunmatched
- Writing Skillsunmatched
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