Sai Mahesh Nadukuru Email & Phone Number

Copenhagen, Dk

Ballerup, Denmark

Søborg, Denmark

1. Create a standardized validation package and approach for specific SaaS software solutions, that can be applied to multiple different pharma clients as Validation Consultant.2. Creating Change Requests in Cherwell for all the changes recorded as QC consultant.3. Assist with and drive the qualification of a number of different QI (Qualified Infrastructure) tasks.4. Leading/Fesilitating IT Quality Risk Assessmnet, PQ scripts.5. Author Validation Test Plans.6. Gathering User Requirement Specifications.

København, Capital Region, Denmark

1. Performing dry runs and executing test cases in Microsoft Azure (software verification).2. Performing GAP analysis for various project and company-related procedures and documents.3. Assisting with documentation for CE marking process (Submission to Notified Bodies).4. Technical Writing of SOPs, instructions, and related documentation. Project and Product documentation and deliverables, support and supervision.5. Participate in Quality Management System training. And ensuring that the Dawn Health Quality System is operational and up-to-date and in compliance with the regulatory standards (MDR, GDPR, etc.) and guidance's (MDCGs and MEDDEVs) and GAMP5.6. Good knowledge of international medical standards ISO 14971, ISO 13485, IEC 62304.

Hørsholm, Capital Region, Denmark

• Data gathering through expert interviews within SMEs and MNCs.• Authored SOP about Risk Management and Post Market Surveillance procedure.• Optimization of User Requirement Specification (URS).• Support function towards sales and marketing.

Bengaluru, Karnataka, India

1. Hands-on experience with complaint handling and medical device Vigilance reporting to the regulatory authorities. Good understanding of applicable regulatory requirements in Quality System Standards. E.g. ISO 13485.2. Complaint Handling Specialist- collecting and analysing PMS data, i.e., recording, analysing, and reviewing complaints as per product malfunction and failure analysis codes for various Medical devices.3. Technical insight into post-marketing surveillance, risk management, customer service, root cause analysis, CAPA, and quality assurance. 4. SPOC (single point of contact) for the clients dealing with translations. Managed and supported different internal and external stakeholders from various countries. Mailbox coordination and customer relationship management.

Master'S Degree, Engineering/Industrial Management

Activities and Societies: 1. Winner in the regional round of "EBEC (European BEST Engineering Competition)" hosted by Microsoft and "Hack.

Bachelor'S Degree, Industrial Engineering, 7.19

Activities and Societies: 1. Awarded with "Certificate of Excellence" in the photography competition at the district level in March 2014..