Akash Awasthi

FAQ About Akash Awasthi

• What is Akash Awasthi's address?

  Akash Awasthi is located at
  Delhi, Delhi, India

• What is Akash Awasthi's job title?

  Akash Awasthi is a
  Currently associated with IQVIA, as Head – IT Compliance & QM, India into Product Development division of eCOA (electronic Clinical Outcome Assessment) BU with 16+yrs of industry experience in Quality Management (QM), Compliance & Risk Management, Computer System Validation (CSV), Quality Assurance(QA) & Quality Control (QC) functions with last 12+ years primarily with Clinical Studies, Drug safety & PV domains. ▪ As part of organizational harmonization, successfully lead the team to develop, implement and roll-out improved Validation practices, SOPs and delivery model based upon SAFe and Agile best practices for SaaS platforms. ▪ Supporting the Global Head – QA and Governance in regulatory GxP audits and acting as SPOC to respond to customer audit queries and drive through to represent Organizational process, SOPs and product Quality Management Systems. ▪ Experience in global Vendor management & Governance working with third party IT vendors to create & support cross-functional validation strategy & representing as Organizational QA. ▪ Directed the Sr. Mgmt. of Quality Systems program including, Internal Audits outcome, Improvement Areas, Trainings, Change Control & Val. procedures, CAPA as well as Annual Product Quality reviews. ▪ Conceptualized, developed & Implemented the Global Regulatory Compliance Requirements Assessment process, applicable across FDA, EMA, GDPR, PMDA regulations from scratch to be reused at every product release. ▪ Involved in hosting, conducting Onsite as well as offshore support for all the regulatory audits (customers, internal & vendors) involving IQVIA suite of products and GAMP compliance and ensuring of no critical & major observations. ▪ Recruited, mentored & leading a team of Quality Managers & Leads supporting key strategic delivery accounts. ▪ Pharmacovigilance and Argus Suite specialist with relevant 12+ years’ experience primarily worked on Argus Safety, Argus Insight & Argus Mart products including end to end Installation, Upgradation, Implementation & Validation of Argus Safety, Argus Insight and Console configuration. ▪ Good understanding of EU Annex. 11, EMA, FDA and ICH regulations, 21 CFR’S, GAMP, GxP requirements along with knowledge of SOPs, SDLC and testing processes. ▪ Experience in Creating/Reviewing Validation documents across the Validation Life Cycle like Master Validation Plan (MVP), Protocols (IQ, OQ, PQ), Incident Report & Records like records (e.g. Change Control, NCs and CAPAs), RTM, Validation Summary Report - GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting. Iqvia

• What industry does Akash Awasthi currently work in?

  Akash Awasthi currently works in the
  Iqvia

• What is Akash Awasthi's area of expertise?

  Akash Awasthi specializes in
  Currently associated with IQVIA, as Head – IT Compliance & QM, India into Product Development division of eCOA (electronic Clinical Outcome Assessment) BU with 16+yrs of industry experience in Quality Management (QM), Compliance & Risk Management, Computer System Validation (CSV), Quality Assurance(QA) & Quality Control (QC) functions with last 12+ years primarily with Clinical Studies, Drug safety & PV domains. ▪ As part of organizational harmonization, successfully lead the team to develop, implement and roll-out improved Validation practices, SOPs and delivery model based upon SAFe and Agile best practices for SaaS platforms. ▪ Supporting the Global Head – QA and Governance in regulatory GxP audits and acting as SPOC to respond to customer audit queries and drive through to represent Organizational process, SOPs and product Quality Management Systems. ▪ Experience in global Vendor management & Governance working with third party IT vendors to create & support cross-functional validation strategy & representing as Organizational QA. ▪ Directed the Sr. Mgmt. of Quality Systems program including, Internal Audits outcome, Improvement Areas, Trainings, Change Control & Val. procedures, CAPA as well as Annual Product Quality reviews. ▪ Conceptualized, developed & Implemented the Global Regulatory Compliance Requirements Assessment process, applicable across FDA, EMA, GDPR, PMDA regulations from scratch to be reused at every product release. ▪ Involved in hosting, conducting Onsite as well as offshore support for all the regulatory audits (customers, internal & vendors) involving IQVIA suite of products and GAMP compliance and ensuring of no critical & major observations. ▪ Recruited, mentored & leading a team of Quality Managers & Leads supporting key strategic delivery accounts. ▪ Pharmacovigilance and Argus Suite specialist with relevant 12+ years’ experience primarily worked on Argus Safety, Argus Insight & Argus Mart products including end to end Installation, Upgradation, Implementation & Validation of Argus Safety, Argus Insight and Console configuration. ▪ Good understanding of EU Annex. 11, EMA, FDA and ICH regulations, 21 CFR’S, GAMP, GxP requirements along with knowledge of SOPs, SDLC and testing processes. ▪ Experience in Creating/Reviewing Validation documents across the Validation Life Cycle like Master Validation Plan (MVP), Protocols (IQ, OQ, PQ), Incident Report & Records like records (e.g. Change Control, NCs and CAPAs), RTM, Validation Summary Report - GxP Regulatory Assessment, Risk Assessment, Validation Planning & Validation Reporting.

• Which languages does Akash Awasthi speak? 

  Akash Awasthi speaks the following languages:
  No languages available.

• Which industries has Akash Awasthi previously worked in?   

  Akash Awasthi has prior experience in the following industries:
  Iqvia , Iqvia , Iqvia , Kronos , Oracle , Grapecity , Wipro Technologies

• What is Akash Awasthi’s work experience?  

  Akash Awasthi has the following professional experience:
  Iqvia , Iqvia , Iqvia , Iqvia , Kronos , Oracle , Grapecity , Wipro Technologies .

• How can I find Akash Awasthi on LinkedIn?  

  You can view Akash Awasthi’s
  LinkedIn profile at LinkedIn URL.

• What are Akash Awasthi’s work email addresses?  

  Akash Awasthi’s work email addresses are
  [email protected].

• What company does Akash Awasthi work for?  

  Akash Awasthi works at
  Iqvia