Description
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
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)