Validation Analyst

RESPONSIBILITIES:

- Gathers and documents business requirements for projects.
- Works to understand client's business requirements.
- Converts requirements into User and/or Functional specifications.
- Works with team members to determine timetable for user requests.
- Leads requirements gathering and validation related tasks and activities within a client/business area, with minimal oversight.
- Acts as a liaison between the business and the development staff/vendor to ensure proper implementation of requirements within the expected timetable.
- Communicates any material modifications of the business requirements to the client.
- Independently leads validation related tasks and activities within a client area, providing oversight on a project or multiple projects.
- Creates and executes validation test scripts and document test results in accordance with standards (Manually or in Quality Center).
- Ensures that project documentation is in compliance with policies and procedures.
- Organizes, coordinates and gathers requirements to perform Functional, Integration and/or Regression tests.
- Provides monthly reports on of validation activities in the organization to Validation SME and/or Manager.

SKILLS

MUST have ability to coordinate/facilitate approval of Requirements Specification deliverable independently. MUST have prior experience in creating Change Requests, Developing Validation Plan, Summary Reports, Traceability Matrix and other project documents created during Computer Systems Validation Processes. MUST independently develop the testing strategy for large and medium sized projects and develop the overall Validation plans and timetables. 5 to 7 years of experience in the Pharmaceutical industry. Excellent verbal and written communication skills, Customer Service focused; Information Technology background, experience within a Quality/Regulated environment including SDLC. Strong interpersonal and technical writing skills and the ability to interact across divisional boundaries. Ability to manage multiple tasks and projects simultaneously, and to prioritize work, goals and tasks per the divisional and corporate objectives. Ability to report results clearly and concisely. Sound reasoning and ability to quickly analyze and solve complex problems. Significant work activities and conditions, continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day). Experience with Quality Center (HP Quality Center) preferred.

Synectics is an Equal Opportunity Employer.