Ayyappa Vengalthuri

Looking forward to pursue an environment which provides me opportunity to enhance my knowledge, experience in Quality, Information Security, Audits and Compliance, documentation, having experience in Quality Hub tool/ JIRA, VLMS, QMS ISMS, CMMI GxP, 21 CFR Part -11, Salesforce, GAPM-5, Data Management, Internal, External audits, Vendor assessment audits, SDLC knowledge and serve best to the company. Collaborative leader with dedication to partnering with coworkers to promote engaged, empowering work culture. Documented strengths in building and maintaining relationships with diverse range of stakeholders in dynamic, fast-paced settings.

• ISO 9001:2015 Certified QMS -Lead Auditor, CQI-IRCA (International Register of Certificated Auditors)
• ISO 27001:2013 Certified ISMS Lead Auditor, CQI-IRCA (International Register of Certificated Auditors)
• HIPAA (Business Associates), HIPAA Exams
• Information Systems Auditing, Controls and Assurance, The Hong Kong University of Science and Technology
• Computer System Validations and DI, QRM, QMS, RCA, USP
• Scrum Master & Agile
• Handling of RCA, CAPA , Data Integrity, Quality Events, Non Conformances, Audit reports,

• Received Special Recognition from MD for leading the team and implementing QMS tools and training teams on Process SOP & Tools. enabling the company to face ISO 9000 & Customer Audits successfully.
• Best Team Award at Cloudbyz across the organisation. (Sep-2021 & 2023)
• Received an Award & Special reward from Managing Director for implementing the QMS systems in various departments of lake enabling the company to face EU Regulatory Audit successfully (Inspection date: 18/09/2108-21/09/2018) @ Lake Chemicals Pvt.Ltd Bangalore.
• Actively Performed Internal Audits Vigilance and Surveillance and faced USFDA without any major observations (USFDA- Inspected i.e. (11-09-2017-15-09-2017) @Malaysia.
• Have done successfully Internal and External Audits (Visited China, Malaysia for Supplier and Contract Laboratories Audits and Make reports and CAPA)

• Having good exposure in Agile and Waterfall approaches, functional requirements, process modelling and completed product and project management lifecycle.
• Monitoring the compliance activities and responsible for the effective and efficient selection, qualification and quality management of IT suppliers, indirect management of the supplier quality managers and communication and escalation of major issues to the management as Management representative.Proactively collaborated with project & Product teams, offering invaluable insights & best practices.
• Respond to client questionnaires, surveys and audit requests
• Facilitation on Project Management process and Support Functions ( HR, IT, Admin, Pre-Sales, Marketing etc., )
• Preparation and review of SIG questionnaire and provide feed back
• Performing gap analysis on process against various standards (ISO, CMMI)
• Providing QMS( 9001) and ISMS (27001) facilitation to projects and departments
• Facilitate project teams in identifying issues and risks, metrics, document creation, review and approval.
• Conducting Internal audits, tracking closure of NCR's and Conducting QMS training.
• Handled projects from various clients from diverse industry domains viz., Pharmaceuticals, CROs, Life Sciences, Clinical Research, pharmacovigilance domain and drug safety applications - Argus & other regulatory service providers, etc.
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