Computer Systems Validation Specialist - London - Permanent
Our client is a leading life science software solutions business. At present they are seeking a Computer Systems Validation Specialist on a permanent basis at their London based office.
Experience ● Relevant degree in a Scientific or Technical discipline and will have experience in the following key areas ● Proven industry experience in a CSV role within the pharmaceutical industry. ● Working knowledge and practical experience with CSV for laboratory and ERP systems as well as required compliance within the pharmaceutical industry. ● Verifiable experience in Computer Service Verification CSV and can show examples of previous work
Responsibilities ● Responsible for a number of projects requiring validation work in a GMP environment ● Responsible for validating various computer systems which will include a variety of ERP based systems and Laboratory systems within a GMP environment. ● Ability to work on projects that include networking standalone systems, and the addition of new instruments to ensure that they are compliant to GAMP5 and regulatory guidelines ● Significant experience across CSV within the pharmaceutical industry. This will be across both Laboratory and ERP systems. ● Utilise experience and knowledge of GAMP5 regulations, Annex 11 and CFR Part 11 to ensure that computer systems are validated in a timely manner
Personal qualities ● A creative thinker and a reliable and efficient doer ● Can explain and describe complex system interactions clearly and efficiently ● Experience with laboratory processes ● Eager to learn new things every day and does not constrain themselves to a narrow field of knowledge ● Can work well in a team but is also independent, well organised, and self-driven