Abhishek Jain - PMP, CSQA, CSM

We serve various Pharmaceutical, Life Sciences and MedTech clients and contributing to the successful completion of their IT GxP Quality, Regulatory Compliance and Validation (CSV) goals. # We specialize in the understanding and implementation of GxP regulations, 21CFR Part 11, EU Annex 11, Data Integrity principles, ISO13485, ISO14971, GAMP5, ICH Q9, Q10 and CSV/CSA throught a system's life cycle. # We excel in establishing and running Post-production Support & Managed services portfolios to ensure systems remain in a Validated state and any changes are made as per Quality Control procedures. # We certify QMS systems via review, SOPs fit-gap asssessement and remediation. # We provide services to complete annual Periodic reviews, Deviation, CAPA, Effective-checks and Non-conformance closures to clear QA backlog and strengthen audit/inspection readiness.

New implementation of PTC Windchill PLM ERP system. Partner with senior architects, system SMEs, various globally situated business teams, user-acceptance testers, vendor teams, implementation partner teams and system validation team for day to day work. Perform impact assessment, and define a robust CSA framework and validation strategy for such a huge (2000+ requirements) implementation. Author, review, approve and execute standard CSV deliverables. Validate the Data Migration approach, strategy with respect to field mapping, balancing, sampling techniques, report generation and data export from legacy Siemens PLSM system.

Understand the advanced and complex supply chain and data management in providing cell therapy and gene therapies at all stages of clinical/commercial development.

Understand the patient journey and the comprehensive landscape of systems supporting the enrollment, sourcing, reimbursement, storage, distribution and administration of specialty drugs in a highly patient-centric environment enabling the end to end Patient Support programs (PSPs).

Olympus is a global leader in Life Sciences research & devices specializing in medical and scientific solutions, by producing an array of optical, digital and surgical solutions & devices e.g. videoscopes, lasers, microscopes etc. Accountable for maintaining the validated state, quality and regulatory/GxP compliance of all on-going releases, upgrades, patches, bug fixes and Change Management for Etq Reliance, an organization-wide SaaS-based QMS used for Device Complaint Management. Collaborate with Engineering and Business teams on a daily basis to plan/lead the testing & validation team and effort. Directly manage the release schedule, testing and validation scope, business requirements process clarification, plan and perform validation activities from inception till go-live. Author, update and maintain the CSV/Validation deliverables namely Validation Plan, URS, FRS, CS/DS, RTM, OQs, PQs and VSR. Manage customer interface and communication.

Accountable for the GxP quality, compliance and validation of a portfolio of computerized systems’ implementation life cycle and change management. First escalation point. Manage multiple projects. Drive business growth by improving customer loyalty through enhanced customer relations and delivery excellence. Incorporate strategic options when defining project/program scope with customer. Manage customer interface and communication. Provide tactical/day-to-day customer-facing leadership for assigned projects. Actively participate at meetings with internal & external stakeholders. Manage, coordinate and/or conduct the validation activities throughout the validation life cycle which involves validation planning as per industry standard GAMP-5 risk-based validation approach (functional risk assessment), GxP/ Systems/ GDPR/ Data integrity/ 21 CFR Part 11 assessments, data migration qualification, business continuity and disaster recovery planning, validation coverage via installation, operational and performance qualifications (IQ/OQ/PQ), deviation and CAPA management and review/author validation summary reports. Manage internal/external audits and inspections.

Otsuka is a globally situated pharmaceutical company headquartered in Japan. It is committed to offer innovative products to serve those with unmet medical needs and go beyond healthcare to improve the well-being of patients. Accountable for maintaining the validated state, quality and regulatory/GxP compliance of all on-going releases, upgrades, patches, bug fixes and Change Management for Oracle Argus Safety and Empirica Signal. Collaborate with Product Vendor, Implementation Partner and Business teams on a daily basis to plan/lead the testing & validation team and effort. Directly manage the timelines, testing and risk-based validation (RBV) scope, business process and functional requirements gathering, business case analysis, System Risk & Impact Assessment, plan and perform validation activities from inception till go-live, decommission and retention. Perform Business Continuity and Disaster Recovery testing. Author, update and maintain the CSV/Validation deliverables namely Validation Plan, URS, FRS, CS/DS, RTM, OQs, PQs and VSR. Report daily/weekly/executive statuses. Participate in regulatory audits and liaise with customer’s Quality Assurance & Compliance staff in the compilation of Corrective/ Preventive Action Plans (CAPAs)/ effectiveness checks/ improvise and update SOPs and global policies.

Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development and commercialization of antiviral drugs used in the treatment of HIV/AIDS, hepatitis B/C, influenza and COVID-19. Accountable for the validation, quality and regulatory/GxP compliance of new implementation of Veeva eTMF, Reportum (a SaaS solution to capture, manage and process adverse event, drug safety and product complaint data) and an in-house Epidemiology Signal Management software based on statistical research and analysis tools like STATA, and post go-live Change Management. Collaborate with Software Manufacturer, Implementation Partner, Customer IT, Internal Engineering & Development and Business teams on a daily basis to plan and perform day to day validation effort. Lead, mentor and guide the testing & validation team. Guide and work hand-in-hand with the IT Project Manager to drive the end-to-end Validation Life Cycle for GxP-regulated systems. Directly manage the project schedule, scope, risks, issues, deliverables, requirements gathering workshops, conference room pilots (CRPs), business case analysis, vendor communications and escalations, if any. Author, review and approve the complete System Validation package including VP, URS, FRS, RTM, OQ, PQ and VSR. Contribute to Business and IT SOPs, training materials and related Operational & Maintenance procedures.

End to end Account and Customer Relationship Management - Engagement, Project Inception, Strategy, Scope, Delivery, Support Handover and Managed Services. First escalation point. Work as a liaison among stakeholders/ sponsors/ business/ service delivery. Understand the business structure and operations of customer's organization and recommend suitable approach and solutions to maximize business productivity and return on IT investments. Business development/ Pre-sales & Solution design. Project Management - Multiple projects. Manage project budget, schedule, scope, communication, resources, risks, issues, change orders and escalations, involve stakeholders as needed and develop mitigation plans. Provide expertise and guidance for complete Deployment, Configuration and Support & Maintenance of Oracle Argus Safety suite. Guide, motivate and mentor the Project team at all times.

Awarded for customer satisfaction, innovation and revenue growth. Accountable for customer relationship and business agreement. Ensuring that IT Service Delivery meets the customer business need. Enhancing customer use of Oracle (Argus) Safety Systems. Ensure PV customer's business IT/Technology requirements are met by implementing Safety systems in accordance with Regulatory compliance and guidelines (US and EU). Drive and deliver Oracle Argus Consulting and Managed Services, including business plan & sales strategy development. Architect, design and build the next generation Cloud hosting PV standards/HIPAA complaint platform for Safety Systems (Argus). Providing Business analytics, business process re-engineering, process change /improvement, evaluate service offerings, pricing re-structure and review/develop revenue generation techniques. Lead sales efforts in areas of expertise and drive thought leadership that creates market differentiation. Foster Practice and Knowledge building. Develop global support teams at different geographical locations, building a 24*7 service desk and ticketing system. Effectively collaborate with cross-functional teams to determine and define PV-related technology solutions/systems that meet regulatory compliance and business requirements. Design best suited safety system implementation for customer based on size, volume and roadmap.