Sanjit Pal Email & Phone Number

Maharashtra, India

Mumbai, Maharashtra, India

Working on Digital Transformation strategies and Qualification of IaaS, PaaS, SaaS, RaaS and other applications.

Mumbai, Maharashtra, India

-Leading the validation and qualification activities for rollout of SAP ECC 6.0 for Getinge South East Asia as part of their APAC DC (Distribution Centre) at Singapore for its SSU units in entire South East Asia.-Requirements Gathering, System Designing, Strategizing the test scenarios and reviewing the test cases to preparing the Release Strategy and the.

Singapore, Singapore

Partnered with a Pharmacovigilance (PV) software product manufacturer for Infrastructure Qualification services.Setting up a CSA Cell for clients using the PV product.Helping clients to adopt CSA by less documentation and more thinking balanced by the science of Quality Risk Management.Helping the PV product manufacturer in addressing client audits.

Mumbai Metropolitan Region

Working on high-value projects with multiple organizations as consulting engagements in the following areas of compliance/validation –Associated with SIVAN Innovation, France & IsraelValidating core health-apps and the development platform for a mobile-app development company focused on early detection of recurrence of Lung Cancer and helping smokers to.

Singapore

Qualification Lead for Leica Aperio Scanner (Instrument validation) for Covance, Japan.Sr CSV Engineer for SIEMENS for EMS-PMS Integration at MSD, Biotech, Singapore. Responsible for QAP, URS, FRA, AIQ, OQ, CDS, RTM Sr CSV and Automation Engineer for MSD Pharm South, Tuas, Singapore on their DataIntegrity Audit Closure project, SOP Review and Harmonization.

India

Lead GxP CSV Auditor for auditing their a) Processes of Human Resources, Technical Delivery, Infrastructure, Administrative, Technical Support divisions with respect to GxP compliance. Auditing the NIIT’s Learning Management and Delivery platform used for delivering training solutions for client BMS, USA. It was a 4-day Audit Schedule.Improving their HR.

India

Working as PQM (Project Quality Manager) for Novartis SAP 4 HANA CoE, Prague, CZ with SAP Team Leader, Subject Matter Experts. Harmonizing, developing and quality-reviewing the FRS, URS of SAP HANA modules.

Singapore

- Commissioning and Qualification of equipments, machines, utilities, instruments and enterprise software as part of Plant and Site Qualification/Validation process.- Strategizing, developing methodologies and advising client to adopt the science of risk-based approach of Validation/Qualification based on US FDA, MHRA, PIC(S) and European Guidelines..

Mumbai Area, India

Hong Kong

Building the CSV framework for the most technologically advanced Pharmaceutical plant in Hong Kong by close interaction with suppliers like Oracle, Waters, Werum, Schaffer, Siemens, MasterControl and a team of highly skilled consultants.Leading a CSV and IT-QA team for ensuring that enterprise-wide GxP IT system are being implemented as per US FDA, PIC(S).

Singapore

Involved in qualifying the Laboratory equipment and software for conducting SLIA, SRA, URS/TS, IOQ and PQ. The equipment involves Spectrophotometer, HPLC, Drying Ovens, Incubators, Constant Climate Chambers, ph Meter and Empower software for our client based in Vietnam.Providing consultancy services for Gap Assessment and Compliance Remediation program for.

Mumbai Area, India

Experience in end-to-end validation of ARGUS, ARISg, TrackWise, LiveLink, SharePoint, Waters LIMS, SAP - BI, Finance and Manufacturing with respect to Change Management, Release and Transport Management System.Experience of working onsite in US and EU for Eli Lilly, Pfizer, Roche. Zimmer, Grifols, Gedeon Richter. Verticals covered are Pharmaceutical.

New York City, NY

Building strategies and designing solutions for our client's in North Americas and EU in the regulated sector involving Life Sciences, Pharmaceutical, Medical Devices and Consumer Care companies with respect to providing Drug Safety, Regulatory Affairs, IT Application and Maintenance; and Regulatory IT Assurance service offerings. Managing the existing.

Mumbai Area, India

Donning multiple roles of (a) Senior Compliance Specialist in high-end consulting engagements, (b) CoE (Centre of Excellence) Lead for conceptualizing and implementing new services lines in IT Quality Assurance specific to companies in the regulated sector and (c) Domain Consultant for IT needs in Drug Discovery, Clinical Trials and Supplies business.

Mumbai Area, India

Worked in multiple companies who are IT Consulting, Solutions and Service providers by providing services in areas of Quality Assurance and Testing, Supporting in new product roll-outs and Application maintenance and development areas in different roles like Service Delivery Manager, Account Manager, Project Manager, Business & System Analyst, Knowledge.

Master Of Business Administration (M.B.A.), Computer And Information Systems Security/Information Assurance, Distinction

Project on modernization of Banking Computerization and staying in compliance with RBI.

Bachelor Of Engineering (B.E.), Computer Science, First Class

Specialization in Artificial Language Programming (Turbo Prolog) to diagonize general illness.