Validation Specialist- Senior * 6+ years experience
* Apply FDA, MHRA, and other applicable global regulations to the development of computer systems supporting regulated business processes * Follow SOPs and industry best practices * Conduct training on good documentation and good testing practices * Facilitate the Computer system Validation Risk Assessment to identify governing regulations and validation deliverables during the development of the computer system * Review validation deliverables for projects which are contracted to third party suppliers * Maintain close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues * Assist in planning, implementing, and documenting user acceptance testing * Review computerized systems validation documents such as: o Requirements Specification o Design Specification Required Skills:- Experience with eCTD and Regulatory Submission applications. Duration:- 6+ Months Location:- Wallingford, CT *-- Thanks & Regards, Anil Ling Technologies, Work: 703-880-2640 Extn: 4013 * *[email protected]*
