Hi, This is Kamal from ASK IT Consulting currently I have my below requirement with me and if you feel comfortable with, kindly send me your updates resume with below detail:
*Full name: Visa Status: Current location (city name): Relocation: Email id: Contact number: Availability:* *Position:** Lead Validation Analyst* *Location:** HopeWell,NJ* *Duration:** 6 Months* *Rate:** $50**/**Hour* *Required Skills:* *Validation, GCP, Pharmacovigilance * *Project Description:* Lead computer system validation efforts for systems used in an R&D environment supporting GCP processes. Work closely with software development teams, end users and internal regulatory compliance staff to ensure that validation activities are planned and executed in compliance with internal procedures. Experience in supporting validation efforts in GCP area specifically the Pharmacovigilance area highly preferred. 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. *__** With Regards, Kamal Pandey **Technical Recruiter **Ask IT Consulting** **You Ask, We Deliver! Phone : 631-869-4702 ext-212 Fax No: 631-803-4488 **Email : [email protected] <blocked::mailto:[email protected]> URL : http://www.askitc.com <blocked::http://www.askitc.com/> Yahoo IM: komal_90pandey GTalk: kamal.askit***
