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@novartis.com
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5 phones found area 551, 201, and 732
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Himanshu Shah is listed as Sr. IT CSV Lead at PTC Therapeutics, Inc., a with 965 employees, based in Princeton, New Jersey, United States. AeroLeads shows a work email signal at novartis.com, phone signal with area code 551, 201, 732, and a matched LinkedIn profile for Himanshu Shah.
Himanshu Shah previously worked as Project Quality Manager at Novartis and Owner at Protek Solutions, Llc. Himanshu Shah holds M.S, Computer Engineering from Fairleigh Dickinson University.
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AeroLeads found 1 current-domain work email signal for Himanshu Shah. Compare company email patterns before reaching out.
•Over 20 years of experience in IT Quality, Regulatory Compliance, FDA Guidelines for GxP, FDA Readiness, Audit, Software Validation/ 21 CFR Part 11 Compliance, Business Analyst, Project coordinator, Change Control / Change Management, GAMP model etc. with more than 4 years of experience in Leadership and Management role.•Excellent experience in dealing with client’s day to day compliance issues/ concerns and provides with the resolutions by evaluating the risk. •Co-ordinate with the stake holders of the project •Actively participated in audits for existing Validation documents and drafting an audit report and suggestions based on the best practices in the industry.•Thorough experience with the Software Development Life Cycle (SDLC) approach and documenting validation deliverables.•Very proficient in writing, reviewing, revising and implementing Validation Deliverables. •Extensive experience in preparing Validation Deliverables, performing Gap analysis and preparing Remediation Plan.Specialties: • Regulatory Compliance (FDA GxP,QSR,PDMA,GAMP)• Computer ValidationProject Management
Listed skills include Urs, Quality Management, Chromatography, Mac Os, and 265 others.
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South Plainfield, New Jersey, United States
Handled the computerized system validation of SAP S/4 HANA (SAP ERP System) Release 2021 implementation to track all manufacturing and quality activities, sales, distribution, and inventory control.
New Jersey
• Responsible for assisting Merck with a dedicated team encompassing the leadership role in Validation in the US and the resources located off-shore for the validation support.• Oversee project management and completion of defined tasks and deliverables, including generating test plan for various systems of the program and review deliverables like QAP, QASR, etc.
Project Description: Computer System Validation for the upgrade of the Pharmacovigilance Tracking and Reporting System - PV Works, Version 4.06 from Assured Information Systems Ltd, UK within Schering-Plough Animal Health Corporation to comply with WQS 10, 134 and the applicable regulatory requirements.• Involved in developing Project Plan, System Validation Plan, User and Functional Requirement Specifications, Design Specification, Test Plan Protocol, Installation Verification Protocol, Functional Verification Protocol, Development Summary Report, User Acceptance Testing, Requirement Traceability Matrix, and Validation Summary Report of the PV Works Application.• Involved in developing System specific SOP such as System Access/Training, Backup, Restore, Achieve, and Retrieve.• Involved in Data Migration Plan for the PV Works project from Version 3.2 to Version 4.06.
Responsible for managing 21 CFR Part11 remediation for various systems used for Pre-clinical trial under 21 CFR Part 58 during the drug discovery phase such as Packard Multiprobe Pipette system, TomTec Quadra system, Biotek’s Microplate Reader, and Safety Pharmacology Evaluation in accordance to Schering-Plough Research Institute (SPRI) standards and FDA Guidelines.
Involved in Computer Validation of a global ARISg – BusinessObjects XI on Safety Reporting Application (SRA) for Eisai Network Companies and Pharmacovigilance groups in accordance to 21 CFR Part 11.
Involved in Computer Systems Validation in accordance to Wyeth standards, FDA Guidelines, GMP and 21CFR Part 11 for various Systems such as BAS, LMS, PMS, and Bosch Vial Filler.
Other employees you can reach at ptcbio.com. View company contacts for 965 employees →
Cherilyn Quizan
Colleague at Ptc Therapeutics, Inc.New York City Metropolitan Area, United States
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Agata Bator
Colleague at Ptc Therapeutics, Inc.Warsaw, Mazowieckie, Poland
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Hannah Brennan
Colleague at Ptc Therapeutics, Inc.Greater Oxford Area, United Kingdom
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David Bastyr
Colleague at Ptc Therapeutics, Inc.Venetia, Pennsylvania, United States
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Lakshman Samala
Colleague at Ptc Therapeutics, Inc.South Plainfield, New Jersey, United States
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Angela Church
Colleague at Ptc Therapeutics, Inc.Charlotte, North Carolina, United States
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Sandra Shahinyan
Colleague at Ptc Therapeutics, Inc.Zurich, Switzerland
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Lanqing Ying
Colleague at Ptc Therapeutics, Inc.United States
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Nabin Ghale
Colleague at Ptc Therapeutics, Inc.San Bruno, California, United States
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Lucia Oliveira
Colleague at Ptc Therapeutics, Inc.New York City Metropolitan Area, United States
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Quick answers generated from the profile data available on this page.
Himanshu Shah works for PTC Therapeutics, Inc..
Himanshu Shah is listed as Sr. IT CSV Lead at PTC Therapeutics, Inc..
AeroLeads has found 1 work email signal at @novartis.com for Himanshu Shah at PTC Therapeutics, Inc..
AeroLeads has found 5 phone signal(s) with area code 551, 201, 732 for Himanshu Shah at PTC Therapeutics, Inc..
Himanshu Shah is based in Princeton, New Jersey, United States while working with PTC Therapeutics, Inc..
Himanshu Shah has worked for Ptc Therapeutics, Inc., Novartis, Protek Solutions, Llc, Merck, and Sandoz.
Himanshu Shah's colleagues at PTC Therapeutics, Inc. include Cherilyn Quizan, Agata Bator, Hannah Brennan, David Bastyr, and Lakshman Samala.
You can use AeroLeads to view verified contact signals for Himanshu Shah at PTC Therapeutics, Inc., including work email, phone, and LinkedIn data when available.
Himanshu Shah holds M.S, Computer Engineering from Fairleigh Dickinson University.
Himanshu Shah is listed with skills including Urs, Quality Management, Chromatography, Mac Os, Traceability Matrix, Consulting, Clinical Trials, and Restore.
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