One of the fastest growing and recognizable Informatics Solutions companies in the world is seeking a Software Validation expert to join them in Ludwigshafen, Germany. This role will be fully office based. An international company with offices worldwide, they have a reputation for being experts in their field regarding laboratory informatics systems. You will be required to carry out on-site testing and validation of software systems to improve the quality and document compliance of the client’s computer systems with applicable regulations.
Working predominantly with a major client in the Mannheim/ Ludwigshafen region, this role will involve validating software systems for a variety of global leading pharmaceutical and life science organizations.
- Experience of working in a Validation role within the pharmaceutical/ life science industry
- Demonstrable specific expertise in Computer Systems Validation (CSV)
- Experience of user requirements, system requirements and functional requirements specification
- Develop and execute validation and test plans such as IQ, PQ, and OQ
- Experience of planning and managing delivery of validation projects and procedures to meet current GMP regulations and guidelines, industry best practice and company policy.
- Experience of validating electronic records such as 21 CFR Part 11, and Annex 11
- Able to manage stake holders effectively