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 final Validation Report.

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 quit the habit thus improving patient outcomes for Cancer survivors. Associated with AB-Cube, Pharmacovigilance/Drug Safety software company, France Consultancy/Documentation by reorganizing and creating the QMS (Quality Management System) structure and its components. Helping them in infrastructure qualification as part of Data Centre relocation.Validating data migration project from ARGUS to SafetyEasy applicationAssociated with a global Fortune 10 Pharmaceutical, Switzerland for –Solutions-assurance and consulting services. Primarily validating applications for being published on the Web, Social and Mobile media. Working on qualifying an unified platform for IAM (Identity and Access Management) and CPM by SAP CDC.Associated with an AI/ML/Data analytics start-up for –Validating a AI/ML based Case Processing, Triaging and Regulatory reporting application for a Top Cosmetics manufacturing company as part of Cosmetovigilance.Leading and implementing validation/qualification strategies and methodologies on AI/ML/DL Data Analytics products and solutions for Pharmacovigilance operations.Building from grounds-up, fully-validated products complying with regulations and company-wide policies for hosting AI/ML/DL products on a SaaS model.Creating and evolving a Quality culture in the organization where Quality is built-in at every stage of the product development life-cycle process.Reporting and working closely with the Leadership team (CSO and CEO) for conceptualizing cutting-edge and cost-effective AI/ML/DL Data Analytics platform that would help enhanced patient safety.

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 for Plant Operations and Maintenance, Review of their Change Requests in Automation, ERMD and Data Integrity Audits.

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, Technical Delivery and Infrastructure processes aligning with GxP processes.Validating the Salesforce.com platform used to deliver Learning Management and training solutions to BMS, USA.

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.- Working as part of team to investigate, strategize, correct and institute preventive measures for Information systems (R&D, Clinical, Laboratory and Manufacturing) affected by Data Integrity (DI) issues as investigated by regulatory authorities or self-inspections.- Developing and imparting training to clients and internal teams on adoption of lean risk-based approaches towards validation and creating CSV DI strategies.- Responsible for Validation of Aperio's FL Scanner series (AT2 ScanScope (Tissue Slide Scanner)) and eSM of Leica Biosystems, APAC region as part of CAI's exclusive Qualificaiton partnership arrangement with Leica Biosystems.

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) guidelines and Department of Health, Hong Kong regulations.Responsible as part of a team for ensuring that MES, WMS, WCS, SCADA, eDMS, eTMS, Oracle ERP system undergo the cycle of Infrastructure Qualification, IQ/OQ/PQ cycles with Requirements and Specification developed jointly.Reviewing and approving as a SME the CSV policies, procedures, SOPs and templates necessary for implementation of IT systems.Harmonizing the business, functional, user requirements of 2 different plants in Hong Kong to have a unified approach towards validation/qualification.Responsible for reviewing the Supplier’s Audit report and findings and deciding on further course of action towards their involvement in validation/qualification process.Guiding the IT Team for conducting Infrastructure Qualification for the state-of-the art Server Room at upcoming site.Investigating, planning the documentation path for closing the CSV gaps in the existing plant with the QC and QA team post-audit conducted by Department of Health, Hong Kong.Acting as the approving authority of manpower budget allocation for ensuring CSV activities as part of implementation of IT systems.Designated as a first point of contact for Department of Health, HK and US FDA audit with respect to IT QA and CSV documentation.Responsible for KPI setting of team member and appraising their performance twice a year.Member of the Strategic Review Board held to review the progress of the new plant facilities on a quarterly basis.

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 their MES, BMS and Laboratory Equipment for a Big Pharma based at Singapore, which is headquartered in Switzerland. Conducted IQ OQ and PQ for Aperio's Satellite Server and AT2 ScanScope (Tissue Slide Scanner) of Leica Biosystems for Biocon Bristol Myers Squibb Research Centre at Bangalore, India. Spearheading qualification of Siemen’s SCADA Clean Utilities systems, (a) Purified Water System, (b) Water for Injection System, (c) Clean Steam System. Validated Siemen’s SCADA Upgrade Software of WinCC 7.3, WinCC 7.3 Audit, and Simatic Step 7. Completed qualification of IBM's Maximo 6 (Calibration Management, Asset Management, Work Management, Inventory Management, Administration and Security Setup, Data Loading) through IQ and OQ execution.Qualification of Siemens BMS (Building Management System) and Schneider EMS (Environmental Monitoring System) as part of IQ, OQ and PQ development and testing.Validation/Qualification of BioVoke for a client based in Singapore. Responsible for structuring the business process of the client around BioVoke. Positioning Paper on the BioVoke’s compliance towards 21 CFR Part 11 and EU GMP Annex 11 was created and approved.Leading Validation/Qualification projects for CAI’s clients in South East Asia in MES/Plant Automation and Testing/Integrated Process Environment business areas.Developing Risk-based Qualification Project Management plans for putting into production Manufacturing GxP equipment, devices, instruments, HMI and MES systems.

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, Medical Devices, Life Sciences, Healthcare.Value-cycle chains covered are Drug Discovery, Clinical Supplies, Clinical Trial and Data Management, Drug Safety System, Anti-counterfeiting.Systems Compliance Consulting Gap Assessment Consulting and Rapid Remediation ProjectsSystem/Application Decommissioning/ Retirement High Risk Supplier/Vendor AssessmentIT Asset Portfolio AssessmentCompliance Management- Systems and Processes Core Computer System Validation (CSV) servicesProspective/retrospective/ Re-validation of Enterpise-wide systemsDashboard-based Periodic Review/Security ReviewAudit and Inspection Audit Preparedness and Audit Readiness servicesChange Management and Release Management servicesProblem and Incident Management ServicesQuality Assurance Activities - Document Management and Content Management servicesSupporting Validation services CSV SOP/IT SOP Management – Upgrade, Harmonization and Periodic ReviewTechnical Writing/ Technical AuthoringElectronic Document Management and Workflow Management servicesTesting and Qualification Services Instituting risk-based testing methodologyTest Strategy and Test Process ConsultingManaged Testing Services by providing end-to-end Testing and Qualification ServicesRisk-based Test Scenarios and Test Execution MethodologyEnd to end IQ, OQ and PQ Test StrategyDocumentation Management of IQ, OQ and PQ

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 clients’ engagements and capitalize on latent business opportunities by conceptualizing and implementing client-specific Account Growth plans in the European sector.Working closely with global Brand Management team,to participate in Client Summits, Industry Conclave, Seminars, Webinars and related corporate philanthropic activities.Reaching out to captive SMEs and industry captains as part of Thought Leadership exercise to carve a niche for my company as part of strengthening the brand-building exercise.Provide Leadership and Management oversight on Quality Assurance activities for GMP-critical IT Assets, Processes, Procedures and SOPs, which are subjected to US FDA, EMA and MHRA Audits and Inspections for our Pharmaceutical and Medical Devices clients.Engage in Advisory and Consulting services for our clients to devise strategies to respond to amendments in IT Regulations and compliance guidelines and continue building on Process Improvement initiatives.

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 divisions for Life Sciences and Pharmaceutical companies. Building strategic plans and support them in implementation leading to business growth making the CoE as a sole profit center.Providing leadership and guidance on inorganically and organically developing competencies by hiring competent resources, developing GxP related processes, SOPs and guidelines for implementing them.Sales and Marketing responsibilities include but is not limited to -Creating, developing new service offerings or fine-tuning existing offerings aligning it with our existing customer’s increasing demands leading to enhanced business opportunities in outsourcing deals, Unlocking business opportunities by participating in pre-sales and client presentations for prospective and existing customers.Participating in creating and initiating short-to-medium-to-long term solutions ensuring business sustainability of the CoE.Operational growth initiatives for CoE include but is not limited to -Sourcing, technically-developing, and sustaining resources for developing and maintaining high-competency levels within the CoE, Harmonizing and aligning corporate-wide Quality Management Systems, Project Management Systems with US FDA and EMEA regulations.Defining guidance towards creation of market-relevant training for Pharma accounts and monitoring its effective implementation.

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 Management Champion, Documentation Engineering and also as a Corporate Trainer in my first job. Gained domain experience and business process knowledge by serving clients in Banking and Finance, Shipping, Pharmaceutical and Content Providers and Distributors in Online Learning space.

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.