- Site Subject Matter Expert (SME) person and co-ordinator for computer validation/test activities.
- Site SME for software validation during internal and external audits.
- Ensure regulatory compliance with internal and external validation regulations, particularly with our client's corporate non-device software requirements.
- Ensure relevant procedures are kept up to date and maintained to the relevant company standards and to industry best practice.
- Provide guidance and assistance with the preparation of validation protocols, test protocols, software design specifications, and associated documentation for all applications supporting the quality system and equipment and automated systems.
- Participates on project teams to develop clear specifications, evaluate feasibility of concepts, and provide estimates for System designs.
- Provides guidance, training and direction the non-device software lifecycles to staff across various functions. Provide software validation/compliance/part 11 leadership.
- Take part in vendor audits of critical equipment vendors.