Saurabh Arora

FAQ About Saurabh Arora

• What is Saurabh Arora's address?

  Saurabh Arora is located at
  Basel, Basel, Switzerland

• What is Saurabh Arora's job title?

  Saurabh Arora is a
  17 Years as SME in IT Quality compliance with setting up the direction & driving strategy for the IT Quality for multiple portfolios i.e. Digital Data and IT, TechOps Quality & IT. Supporting digital transformation, standardization, modernization, & innovation, and implementation of AI, strengthening IT QMS by implementing & updating procedures related to Deviations, Investigations, defining procedure for CAPA, Risk Management, Supplier Quality, Computerized System Validation (CSV/CSA) which are compliant to norms defined as per EU Annex -11, 21CFR Part11 and Guides GAMP5, ICH. Working as Independent IT Quality Manager on Complex GxP projects is my passion, where Key Global rollouts i.e. Track wise, Customized MES, SAP, BMS, being a business SME, my nature of duties also contributes to driving right digitalization, have fair understanding the entire eco system i.e. Laboratory, Manufacturing, Engineering, and Supply Chain. Experience of working directly at manufacturing sites as well as at global offices, leading the teams to face regulatory Audits & sustaining Regulatory approvals, establishing a culture of Integrity & compliance. Cleaning Validation is the area where i have played a pivotal role implementing at multiproduct facility as a concept, Solid Performance in Batch record review and laying down SOPs for organization as best practice how to review the Batch record effectively. Working with leadership on the business continuity, contributing to winning large deals (>50M USD), handing Deal Pricing System, Participation in domain centric RFPs, staffing estimation, resource planning, and negotiations. track record of supporting company financial growth by creating and maintaining the global functions of multimillion USD. Medical Devices As a Lead Auditor I have done audits to ensure then vendors who are engaged in SaMD delivery are in compliant to the regulations & guides i.e. Software development process defined as per IEC62304, QMS - ISO13485, having established Risk management as per ISO14971. As a Quality manager I have worked on complex SaMD project which is integrated with IoMT enabled Digital Health Platforms (DHPs) along with Data Driven Platforms/PaaS Participation as key contributor by defining on digital health innovation action plan for Quality Compliance start from risk management, their validation by adopting and leveraging SAFe (Scaled Agile framework) where established an integrated approach to ensure regulated compliance is aligned. Value adds, & keeping fair understanding working on COTS, SOUP Infosys

• What industry does Saurabh Arora currently work in?

  Saurabh Arora currently works in the
  Infosys

• What is Saurabh Arora's area of expertise?

  Saurabh Arora specializes in
  17 Years as SME in IT Quality compliance with setting up the direction & driving strategy for the IT Quality for multiple portfolios i.e. Digital Data and IT, TechOps Quality & IT. Supporting digital transformation, standardization, modernization, & innovation, and implementation of AI, strengthening IT QMS by implementing & updating procedures related to Deviations, Investigations, defining procedure for CAPA, Risk Management, Supplier Quality, Computerized System Validation (CSV/CSA) which are compliant to norms defined as per EU Annex -11, 21CFR Part11 and Guides GAMP5, ICH. Working as Independent IT Quality Manager on Complex GxP projects is my passion, where Key Global rollouts i.e. Track wise, Customized MES, SAP, BMS, being a business SME, my nature of duties also contributes to driving right digitalization, have fair understanding the entire eco system i.e. Laboratory, Manufacturing, Engineering, and Supply Chain. Experience of working directly at manufacturing sites as well as at global offices, leading the teams to face regulatory Audits & sustaining Regulatory approvals, establishing a culture of Integrity & compliance. Cleaning Validation is the area where i have played a pivotal role implementing at multiproduct facility as a concept, Solid Performance in Batch record review and laying down SOPs for organization as best practice how to review the Batch record effectively. Working with leadership on the business continuity, contributing to winning large deals (>50M USD), handing Deal Pricing System, Participation in domain centric RFPs, staffing estimation, resource planning, and negotiations. track record of supporting company financial growth by creating and maintaining the global functions of multimillion USD. Medical Devices As a Lead Auditor I have done audits to ensure then vendors who are engaged in SaMD delivery are in compliant to the regulations & guides i.e. Software development process defined as per IEC62304, QMS - ISO13485, having established Risk management as per ISO14971. As a Quality manager I have worked on complex SaMD project which is integrated with IoMT enabled Digital Health Platforms (DHPs) along with Data Driven Platforms/PaaS Participation as key contributor by defining on digital health innovation action plan for Quality Compliance start from risk management, their validation by adopting and leveraging SAFe (Scaled Agile framework) where established an integrated approach to ensure regulated compliance is aligned. Value adds, & keeping fair understanding working on COTS, SOUP

• Which languages does Saurabh Arora speak? 

  Saurabh Arora speaks the following languages:
  No languages available.

• Which industries has Saurabh Arora previously worked in?   

  Saurabh Arora has prior experience in the following industries:
  Infosys , Mylan , Diversified Healthcare Industry

• What is Saurabh Arora’s work experience?  

  Saurabh Arora has the following professional experience:
  Infosys , Infosys , Mylan , Diversified Healthcare Industry .

• How can I find Saurabh Arora on LinkedIn?  

  You can view Saurabh Arora’s
  LinkedIn profile at LinkedIn URL.

• What are Saurabh Arora’s work email addresses?  

  Saurabh Arora’s work email addresses are
  [email protected] .

• What company does Saurabh Arora work for?  

  Saurabh Arora works at
  Infosys