Validation Analyst

Independently conduct, review and evaluate computerized systems for Privacy, System Risk and Part 11 Compliance

- Leads Validation related tasks and activities within a client area, providing oversight on a project or multiple projects
- Ensures that project documentation is in compliance with company policies and procedures
- Develops the testing strategy for large and medium sized projects and develops the overall Validation plans and timetables.
- Develops business relationships with internal IT and QA team members to ensure successful implementation and support of project efforts by ensuring consistent IT Compliance practices.
- Create/Develop test plan, testing strategies and test protocols per approved User and Functional Requirements
- Organize, coordinate and gather requirements to perform Functional, Integration and/or Regression tests
- Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center)
- Provide monthly reports on validation activities in the organization
- Perform system assessment activities to formulate validation plans and strategies

SKILLS:

Experience in Creating Validation Change Requests, Developing Validation Plan, Summary Reports, Traceability Matrix and other project documents created during Computer Systems Validation Processes

- Prefer experience with leading onshore and offshore validation testing teams, working with cloud based software vendors and other consultants.
- Ability to coordinate/facilitate approval of validation documentation independently
- 5 to 7 years of experience in the Pharmaceutical industry in Clinical area preferred.
- Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives.
- Excellent verbal and written communication skills, Customer Service Focused; Information Technology background, experience within a Quality/Regulated environment including SDLC.
- A proven record for success in Computer System validation.
- Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries.
- Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems.
- Excellent attention to detail and time management skills.
- Ability to work independently and with work teams
- PC literate with the following applications: MS Excel, Word, PowerPoint
- Experience with Quality Center (HP Quality Center) preferred.
- Must be able to sit continuously for prolonged periods (more than 2 consecutive hours in an 8 hour day)