Amish Shah
IT Compliance Leader, Auditor & Trainer-csv,csa,data Integrity,gdpr,cgxp,gamp5,21 Cfr Part- 1,qms at Ani Systems
Based in Ahmedabad, India
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Seniority
Other
Department
Other
Location
Ahmedabad
Industry
IT Services and IT Consulting
Company size
7
Contact information
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a•••••••@anisystems.com
Phone
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Background
About Amish Shah
Experienced professional and compliance leader with more than 2 decades of specialized, extensive, qualitative and diversified experience in pharmaceuticals, healthcare, clinical research, life sciences, medical devices and software compliance domain with wide experience in CV, CSA, cGxP, GAMP, GDPR, 21 CFR Part 11, 21 CFR Part 820, EU Annex 11, ISO-QMS, ISO-13485, ISMS and other global standards, regulations, compliance requirements and adherence. A Subject Matter Expert, Auditor and Trainer for cGxP, GAMP, GDPR, CSV, CSA, Data Integrity, QMS, ISO, Software (Automation, Analytical, LIMS) and other global regulations along with current compliance requirements. Expertise: • Compliance Audit & Training - CSV, CSA, Data Integrity, 21 CFR, GDPR, cGMP, GAMP, GxP, Lab Software, ISO-QMS, ISO-13485 and many more • Testing & Validation (CSV, CSA, Spreadsheets, Analyst Software, SAS, PLC, HMI, SCADA, Process Validation, Design Testing) • Gap Analysis, Risk Identification, Risk Mitigation, CAPA • Remediation for Audit Observations • IT Infrastructure with Compliance Requirements • IT Quality Management / Life Sciences IT Compliance / Software Lifecycle Compliance • IT infrastructure (Planning, Design, Implementation and Validation) • Data Automation (Acquisition, Processing, Transmission, Interfacing, Connectivity) • Data Analytics and Statistics
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