Client is looking for a Computer Systems Compliance consultant who is very strong in the Data Integrity space. They are looking for the resource to be strong with the regulations (21CFR part 11, Annex 11, GAMP guidance) but also be experienced enough to look beyond the regulations to assess data integrity and ensure compliance. The DI assessments are done on systems that are already qualified so while having CSV experience is relevant it is not what the consultant will be doing. Consultant will be focused on operational oversight of the systems and quality compliance. The more systems the consultant is familiar with the better, and they aren’t looking for someone who is just strong in the lab or just strong in mfg. Computer Systems are anything within the GxP scope so can be lab, mfg, can be IT infrastructure as well. Persons with IT compliance, IT audit prep, and IT Data Integrity experience are the people to focus on; people who can assess a system for potential risk and being able to prep the IT function for audit/inspection. People who have assessed for compliance and also sorted out compliance issues are those to focus on. A consultant with leadership and coaching experience is needed as this person will work cross functionally as the expert in this space so needs to have that confidence to speak up and educate/coach an audience on DI and Compliance for Computerized Systems.
Skills: Data Integrity, Computerized Systems, IT, Quality
Education: Experience outweighs degree. If candidate comes with more than 10 years of experience, they will focus on their experience rather than their education.
Duration: 6+ months 40 hours per week (no OT)
Start Date: early November
NY: CSV/Data Integrity (231537)