Validation Analyst

RESPONSIBILITIES:

- Lead/support validation efforts and deliverables for systems used for Clinical, Pre-clinical, Global Medical Affairs and Finance/Operations with minimal oversight.
- Develop the validation testing strategy for large and medium sized projects and develop the overall Validation plans and timetables.
- Create and execute validation test scripts and document test results in accordance with company standards.
- Review and evaluate validation assessments for application systems/projects.
- Ensures that validation project documentation is in compliance with company policies and procedures.
- Create and execute validation test scripts and document test results in accordance with standards (Manually or in Quality Center).
- File validation documentation within following Quality Assurance Library guidelines.
- Ensures that project documentation is in compliance with policies and procedures.
- Provide monthly reports on of validation activities in the organization to Validation SME and/or Manager.

SKILLS/QUALIFICATIONS:

- 7 to 10 minimum 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.
- Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
- Experience with Quality Center (HP Quality Center) preferred.
- Associate Degree minimum or equivalent combination of education and work experience.
- Prior Experience with validation of Clinical systems preferred.
- Require prior experience in creating Change Requests, Developing Validation Plan, test scripts, Summary Reports, Traceability Matrix and other validation project documents in the Pharmaceutical industry preferred.