Job for Validation Lead in Boston, MA (Look for only H1B/USC/GC )

Hi Hope you are doing great! Please find the job description below and let me know if you feel comfortable…   Role: - Validation Lead (8+ Years Exp.) Location: - Boston, MA Duration of Project: 12+ Months Contract – W2 and C2C.         Look for only H1B/USC/GC.                Job Details:-   Job Description:  Should have worked on Life Science Computer System Validation, Risk Based Validation Approach 21 CFR Part 11 for Electronic Records and Electronic Signatures SDLC and STLC, Verification and Validation Should have good understanding of project lifecycles and the comprehensive delivery process for GxP systems. Should have extensive exposure to Change Management process. Extensive Domain knowledge of Life Sciences/ Pharma domain. Excellent communication skills, leadership qualities, systematic approach and ability to work under time and resource constraints. Good understanding of ITIL process. Involved in direct client interaction. Competent in conflict management and escalation handling.   Technical Responsibilities: Should have good experience in Computer System Validation, Risk Based Validation Approach, Alignment with GAMP 5 standards Good experience in writing Validation Plans, undertaking Risk Assessments, defining Validation strategies, educating teams on GxP approaches and supporting implementations, writing Validation Summaries. Good understanding of Change Management process (preferably using ServiceNow) Good knowledge of Testing practices in GxP environments Experience with validating and qualifying Cloud based systems 21 CFR Part 11 for Electronic Records and Electronic Signatures SDLC and STLC, Verification and Validation for GxP systems Should have good understanding of project lifecycles and the comprehensive delivery process. Good understanding of typical change management process Preferable to have good knowledge with enterprise wide system implementation (eg. Learning Management Systems, Manufacturing ops etc.)   Relevant Years of Experience: ~ 7 years Must Have Technical Qualifications: Computer System Validation, GxP testing, 21 CFR Part 11, 820. Must Have Business Qualifications:  Competent in conflict management and escalation handling. Nice to Have Qualifications: Computer System Validation, experience in validation of manufacturing systems. Key Responsibilities 1. Own end to end validation of enterprise level systems and their upgrades 2. Be the primary point of contact for Business and Technical teams on Validation strategy and implementation 3. Educate different groups on GxP processes during project execution including alignment with SOPs and the processes to be followed 4. Work on Testing strategy with co-located/remote teams and follow STLC lifecycle to ensure testing is completed as per processes 5. Coordinate with Quality Control/Assurance to ensure adherence to corporate and regulatory standards   Thanks with Regards......? Sr. IT recruiter Yashin Ansari Mohammad 1851 McCarthy Blvd, Suite 112 to 118 Milpitas, CA 95035 Desk: 408-637-5156

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