Soham Bhagwat Email and Phone Number

15 +years in Pharma validation within process, quality, regulatory, and clinical environments. Specializing in Quality Engineering, Validations, Project Management, Software regulatory Analysis/assessment Audits and Training.Regulations/Standards/Guidelines: USA: GMP - FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES (21CFR – Part 11), EU : FMEA / MHRA  Universal: ISO9000:1994/2000. GAMP (Good Automated Manufacturing Practices).Regulatory Skills: Validation experience include o Authoring validation plans o Authoring of IQ/OQ/PQ o Execution of IQ/OQ/PQ activities  Understand GMP and IT systems requirements in a GxP environment. Application support for GxP systems  Understanding/Support and Validation of laboratory systems and chromatography  Expert knowledge of 21CFR Part 11, audit trails, security features, cGMP, GCP & regulatory requirements for automated systems  Excellent communication skills  Proven ability to handle (and thrive on) accountability  Experience making quality assurance and compliance decisions in regards to software development, validation and support.  Experience with all phases of software and infrastructure validation and qualification.  Document experience in working as part of a validation projectProficient or familiar with a vast array of programming languages, concepts and technologies, including:- C & C++ Windows 2K/95/3.X/NT/XP/Me/Vista, - ERPs (e.g. SAP,Progen,JD EDwards)- PLC programming Siemens Step 5 & Step 7 Allen Bradley- RSlogix , Mitsubishi –GxDeveloper & - SCADA systems, Verilog, VHDL. SQL Server- IBM AS400e Application server Unix, DOS, Linux. - Network fundamentals - Novell & Windows.Specialties: Regulatory & compliance benchmarking:Validation & Compliance Specialist experience in Computer System Validation, Regulatory and Compliance Management, Experienced in validation of Pharmaceutical Automatated Manufacturing - DCS, PLC, SCADA, BMS, HVAC Systems which include preparation of documents like Validation Master Plan, User Requirement, Design Specification, Process & Instrumentation Diagram verification.- Business Process validation (ERP)