We are looking for an experienced IT Validation Consultant to develop and grow the validation client department.
Roles & Responsibilities:
Education and Experience
- Provide Validation expertise in Validation strategy and approach
- Ensure regulatory compliance applicable to computerized systems.
- Approve the risk analysis by integrating the regulatory impacts.
- Supervise the Validation team, from planning to the production of the system.
- Approve the Validation plan, the Validation report, each qualification protocol and reports (in accordance with the Validation plan)
- Manage anomalies (if applicable) and approve the action plans put in place
- Approve the production of the IS
- Bachelor’s degree in computer science, engineering life science or related field
- 2 years experience with CSV validation lifecycle management, validation documentation development and 1 year project management, using a risk based methodology.
- 2 plus years Pharmaceutical manufacturing or Medical Device industry experience in computer systems validation, process validation, QA or compliance functions.
- Excellent understanding and experience with industry regulations, standards, and guidelines