Plz send suitable profiles to* [email protected]** Senior Validation Consultant with hpqc and sap experience*
* * *JOB LOCATION: PLAINSBORO, NJ * *Duration:6 months* Project Description: Senior Computer System Validation Consultant with very good HPQC skills as well as some SAP experience. • 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 o CSV Risk Assessment o Test Plans o Test Summary Reports o Data Migration Plan o Pre/Post Executed Test Scripts o Traceability Matrix o Release to Production Statements • Direct and review testing • Provide guidance on quality issues that affect the integrity of the data or the system • Prepare validation summary and test summary reports • Obtain and respond to QA review • Participate in establishing standard quality and validation practices • Independently assess compliance practices and recommend corrective actions • Approve validated computer system related change requests • Monitor regulatory and inspection trends and advise the business on suitable action Required Skills: CSV, HPQC, SAP Thanks & Regards ……………………………….. *Sandeep* Business Development Executive TT Technologies, Inc Voice:516-439-7897 Alt: 212-999-6251 Ext.210 Fax: 212-658-9460 [email protected] [email protected] www.t3incorp.com -- To unsubscribe, reply using "remove me" as the subject.
