We are seeking a Validation Lead / Analyst with experience and expertise in Quality and Compliance Analyst and experience in GxP requirements for Computer Validation, application documentation, testing documentation, administration, training fundamentals and data analysis. The position is a long term consulting opportunity in Swiftwater, PA. The responsibilities of this position will include supporting the various activities such as quality administrative activities, documentation reviews, change management support, testing reviews, and training documentation for initiatives supported by the team.
Project support would include:
- Guiding validation and testing strategy
- Reviewing and approving key project documents (e.g. validation plan, requirements, design, testing, reports).
Application support would include:
- Guiding change controls including impact assessments, change plans and test plans.
- Reviewing and approving change controls and implementation documentation against previously approved change plans.
Support other IS Quality activities as requested (e.g. periodic review, Part 11 compliance audits, training)
The candidates must possess the following skills:
- 3+ years of a working knowledge of Computer Validation
- Computer System Validation using Risk based approach
- Change Management and Electronic Document Management processes
- 21 CFR Part 11