Job Description :
Position Title: Computer Systems Validation (CSV) Analyst
Position Summary:
The primary responsibility of the CSV Analyst is to ensure that all IT activities are performed and maintained in a state compliant with applicable regulatory laws and guidelines and Teleflex policies and procedures. This role coordinates the global quality and compliance activities for all IT environments that are primarily supported from North America and acts as the primary liaison between internal customers and IT.
Responsibilities:
1. Participate in the development, implementation, execution and adherence to validation procedures and methods related to computer systems validation (CSV)
2. Preparation, review and issuing of CSV documents as they related to computer systems:
3. Author, execute, perform, summarize CSV documents: Validation Plans, User and Functional Requirements, Design Specifications, Risk Management Plans,
Installation/Operational/Performance Qualification Protocols, Traceability Matrices, Final Reports, Deviation Handling
4. Identify computerized systems validation needs through assessments and integration with IT Project Management Framework.
5. Experience working effectively in globally diverse teams and matrixed organizations.
6. Experienced in leading global validation & compliance teams on multiple simultaneous projects and systems comprised of both large and small bespoke, configurable and off-the-shelf systems (ERPs SAP, MFG*pro, BMC Remedy etc.
7. Extensive knowledge of regulatory compliance including FDA, SOX and ISO. FDA knowledge to include cGMPs and 21CFR Part 11, ISO13485, GAMP 5 and SOX regulations and guidelines.
8. Comprehensive knowledge of computer software development and project management.
9. Excellent listening skills, strong verbal and written communication skills required.
10. Excellent meeting management skills (agenda, notes, timekeeping, engagement, info sharing pre-meeting
11. Interviewing skills to surface information relevant to the analysis.
12. Technical knowledge of IT systems, including server hardware and software.
13. Ability to prioritize and communicate business needs to minimize negative impact to the organization,
Education:
Bachelor’s Degree in Computer Science, Engineering, Science, or related field
Must have a minimum of 5-7 years’ experience in an FDA regulated industry
Experience in a manufacturing or R&D operation a plus
Through knowledge of cGMP and FDA regulations and Annex 11
Ability to impact and influence people/areas in matters related to CSV and GxP compliance