Prasad R. Email & Phone Number

Tamil Nadu, India

• Lead Regulatory Compliance team for In-vitro diagnostic medical devices and medical devices.• Gap assessment, Remediation plan preparation for technical documents of Medical devices, IVD & Standard compliance.• Remediation of Technical Documents, GSPRs in compliance to EU IVDR 2017/746 and EU MDR 2017/745.• Authoring PMS documentations PEP, PER, CPR, APR, SVR, SSP, PMSP, PMSR, PSUR.• Review of DHF & DMR documents.• Regulatory strategy for EU, FDA, CDSCO, Middle East, South… Show more • Lead Regulatory Compliance team for In-vitro diagnostic medical devices and medical devices.• Gap assessment, Remediation plan preparation for technical documents of Medical devices, IVD & Standard compliance.• Remediation of Technical Documents, GSPRs in compliance to EU IVDR 2017/746 and EU MDR 2017/745.• Authoring PMS documentations PEP, PER, CPR, APR, SVR, SSP, PMSP, PMSR, PSUR.• Review of DHF & DMR documents.• Regulatory strategy for EU, FDA, CDSCO, Middle East, South American countries & Others.• SaMD regulatory submissions involving Laboratory Information Management System.• Handling of Clinical Trial documents including Regulatory Intelligence.• Perform review of Technical, clinical and PMS documents and provide feedback for the authors.• Risk Management activities in compliance with ISO 14971 & ISO/TR 24971.• Product registrations of medical device major’s and India.• Manage customer communications and project management.• Conduct training programs for team members for medical devices requirements.• Support Authorized Representative (AR) and Person Responsible for Regulatory Compliance (PRRC) activities for EU.• Drafting of SOP’s & Manuals.• Actively engage with internal stakeholders and cross-functional client business teams such as Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs. Show less

India

•Quality Assurance & Regultory Compliance for In-vitro diagnostic medical devices and medical devices.•Training SPOC for regulatory group involving collection of training materials and creating e learning module. •Involved in leading a team with the following work profile for EU submission :- Gap assessment for IVDR & MDR devices including ISO standards for Risk Management (14971:2012), IVD test systems - Requirements for Blood Glucose Monitoring Systems for Self Testing Device… Show more •Quality Assurance & Regultory Compliance for In-vitro diagnostic medical devices and medical devices.•Training SPOC for regulatory group involving collection of training materials and creating e learning module. •Involved in leading a team with the following work profile for EU submission :- Gap assessment for IVDR & MDR devices including ISO standards for Risk Management (14971:2012), IVD test systems - Requirements for Blood Glucose Monitoring Systems for Self Testing Device (ISO 15197: 2013) Labelling (EN ISO 18113 - 1 : 2010, 18113 - 2 : 2009, 18113 - 3 : 2010, 18113 - 4 : 2013, 18113 - 5 : 2009, 15223-1 : 2013, 61010 - 1 & 61010 - 2, IEC 61326 - 2 - 6 - 2012), Clinical performance (CLSI EP 05, CLSI EP 09, ISO 17511 - 2003, EN ISO 13612 - 2002), Analytical performance, Safety data.- Remediation plan preparation - Performing remediation activities (as applicable).- Technical writing of : Performance evaluation protocol (PEP), Performance evaluation report (PER), Scientific validity report (SVR), Clinical performance evaluation report (CPR), Analytical performance evaluation report (APR)- Creating Technical Documents as applicable.•Presently involved in a project to streamline of the entire QMS system for client which includes :-Quality Manual-SOPs – Process & Product Level-Audit checklist preparation - Process & Product Level•Additional responsibility as Configuration Controller to verify & maintain the deliverable track record and managing project activities. Show less

Chennai

Noida Area, India

Responsibilities :Review protocol.Review randomization schedule. Conduct in-process and retrospective audit of clinical phase of study to ensure protocol, SOP's and regulatory requirements. Conduct system audit as per system audit plan.Conduct vendor pre-qualification and re-qualification audit.Preparation, review,distribution and maintenance of SOP's.Review and maintain calibration and validation documents and temperature chart records. Issuance of… Show more Responsibilities :Review protocol.Review randomization schedule. Conduct in-process and retrospective audit of clinical phase of study to ensure protocol, SOP's and regulatory requirements. Conduct system audit as per system audit plan.Conduct vendor pre-qualification and re-qualification audit.Preparation, review,distribution and maintenance of SOP's.Review and maintain calibration and validation documents and temperature chart records. Issuance of Logbooks.Review of deviations, CAPA's and change control procedures. Handling of Sponsors. Show less

Noida Area, India

Responsibilities :1. Supervising QA activities and monitor overall functions of QA clinic to ensure the process comply with the requirements of SOP, Protocol, Applicable Regulatory Requirements etc., 2. Training of staffs as per ICH-GCP guidelines and other standards.3. Interacting with Investigators, Clients and other Internal groups. 4. Preparing Audit plans for Internal and External audits. 5. Review of SOPs as per GCP requirements and elaborate the instructions to… Show more Responsibilities :1. Supervising QA activities and monitor overall functions of QA clinic to ensure the process comply with the requirements of SOP, Protocol, Applicable Regulatory Requirements etc., 2. Training of staffs as per ICH-GCP guidelines and other standards.3. Interacting with Investigators, Clients and other Internal groups. 4. Preparing Audit plans for Internal and External audits. 5. Review of SOPs as per GCP requirements and elaborate the instructions to achieve uniformity of performance in the management of clinical trials. 6. Assigning projects to team members after assuring that He/She is trained for particular activities.7. To assure that clinical studies are conducted in accordance to SOPs, Compliance to protocol requirements and applicable regulatory guidelines.8. Review of Clinical Raw Data, Randomization, Protocol, Clinical Reports, PK & Statistical analysis.9. Inspection of clinics and other facility audits for GCP compliances and various regulatory requirements.10. Tracking of Calibration and Validation schedule for clinic and approval of certificates. 11. Maintain Master documents, Manuals, Calibration certificate and Validation documents related to clinic. 12. Planning and conducting of vendor audits, preparation of audit report and ensuring compliances.13. Co-ordination with sponsor and external regulatory audits. 14. Responsible for overall functions of QA group of PHC activities to ensure the process comply with the requirements of SOP, Protocol, Applicable regulatory guidelines etc., and for smooth and timely functioning of the group. Show less

Chennai, Tamil Nadu, India

Primary Responsibilities:Involves both Selaiyur & Chrompet facilities: Carrying out periodic review for adequacies of GCP,GLP,SOP's.Carrying out all applicable Regulatory Compliances.Reviewing study documents related to Clinical Department.In process audit of Accountability,Dispensing & Dosing Investigational Products.Performing periodic inspections and Audit operations related to clinical studies including Facility,Process,Bio Study Audit and Raw Data's.Audit of… Show more Primary Responsibilities:Involves both Selaiyur & Chrompet facilities: Carrying out periodic review for adequacies of GCP,GLP,SOP's.Carrying out all applicable Regulatory Compliances.Reviewing study documents related to Clinical Department.In process audit of Accountability,Dispensing & Dosing Investigational Products.Performing periodic inspections and Audit operations related to clinical studies including Facility,Process,Bio Study Audit and Raw Data's.Audit of study Specific data's - Atleast 20% random sample checks in case of performing QA functions.Review of Clinical study updates.Review of Clinical Study Reports.Review of Blood sample collection deviations.Review & Audit sample collection & transportation of samples.Preparation of Audit certificates.Custodian for SOP's.Distribution of SOP's.Controlled and Uncontrolled documents issuance.Responsible for maintaining the integrity of study documents as per checklist.Handling of sponsors.Involved in training of SOP's & Manuals to new joiners. Secondary Responsibilities:Responsible for the maintenance of archival, "Secondary Archivist". Responsible for destruction of expired archived datas.Responsible for standardisation of "offsite" archival.Responsible for reviewing Bio Analytical data's.Responsible for audit of Bio Analytical study reports. Interim Responsible for "Archival" at Paadi facility that involves GLP dedicated to Pre Clinical studies.Issuance of "Smart Forms" of both study specific and non study specific. Show less

Chennai Area, India

Primary Responsibilities:Involves both Selaiyur & Chrompet facilities: Carrying out periodic review for adequacies of GCP,GLP,SOP's.Carrying out all applicable Regulatory Compliances.Reviewing study documents related to Clinical Department.In process audit of Accountability,Dispensing & Dosing Investigational Products.Performing periodic inspections and Audit operations related to clinical studies including Facility,Process,Bio Study Audit and Raw Data's.Audit of… Show more Primary Responsibilities:Involves both Selaiyur & Chrompet facilities: Carrying out periodic review for adequacies of GCP,GLP,SOP's.Carrying out all applicable Regulatory Compliances.Reviewing study documents related to Clinical Department.In process audit of Accountability,Dispensing & Dosing Investigational Products.Performing periodic inspections and Audit operations related to clinical studies including Facility,Process,Bio Study Audit and Raw Data's.Audit of study Specific data's - Atleast 20% random sample checks in case of performing QA functions.Review of Clinical study updates.Review of Blood sample collection deviations.Review & Audit sample collection & transportation of transport.Custodian for SOP's.Distribution of SOP's.Controlled and Uncontrolled documents issuance.Responsible for maintaining the integrity of study documents as per checklist.Secondary Responsibilities:Responsible for the maintenance of archival, "Secondary Archivist". Responsible for destruction of expired archived datas.Responsible for standardisation of "offsite" archival.Responsible for reviewing Bio Analytical data's.Responsible for audit of Bio Analytical study reports. Interim Responsible for "Archival" at Paadi facility that involves GLP dedicated to Pre Clinical studies.Issuance of "Smart Forms" of both study specific and non study specific. Show less

Broxbourne

Worked as a Kitchner and driver for 10 months from March '14 till November '14 at Bethnalgreen & Cambridge Pizza Hut, then Support Manager for Hoddesdon Pizza Hut belongs to same franchisee.

London, United Kingdom

Started my Part Time job in Pizza Hut working as a Kitchner and Driver. Part Time jobs in such food industries are highly likely to develop Time Management, Swiftness, Individual Responsibility, Self Motivation, Resistivity, Politeness & Business Orientes Skills. Also involved in training the new recruited staffs.

Chennai Area, India

Responsibilities: Employee Offer Letter Generation Employee ID Generation CTC Updation Bank Account Updation Transfers Termination HR Status & Employee Sub Classification Updation Tax Updation Handling Queries (PeopleSoft HRMS related Queries) Reports Generation – Employee List Report, COPS Report, etc.,Additional Responsibilities: Preparation of Global Headcount Classification Report for 13 Geographies  Reports… Show more Responsibilities: Employee Offer Letter Generation Employee ID Generation CTC Updation Bank Account Updation Transfers Termination HR Status & Employee Sub Classification Updation Tax Updation Handling Queries (PeopleSoft HRMS related Queries) Reports Generation – Employee List Report, COPS Report, etc.,Additional Responsibilities: Preparation of Global Headcount Classification Report for 13 Geographies  Reports Generation – Laser Focus reports, Employee List Report, CTC Report, etc., Weekly generating WFM/WFA Reports for Testing Assigning Access to Manager Level 6 & Above to HR Portal SPOC for: Employee Help Desk Global Professional Recruitment Team  Handling Queries Regarding PeopleSoft – Iroz (CRM for Employees attendance related information’s) interface PeopleSoft related Testing – Weekly/Monthly Basis Coordinating with PS – Core Tech team for People Soft related functional issues Supporting employees in 13Geographies for Sutherland Global Services thorough globe (Global Shared Services) Support during the Payroll for: INDIA – Monthly Basis PHILLIPINES – Twice a Month Show less

Handling technical queries for Norton Antivirus.

Master Of Science (M.Sc.,)/ Master Of Technology (M.Tech.,), Nanoscience & Nanotehnology

Master's in Nanoscience & Nanotechnology

Pg Certificate, Biotechnology

Biotechnology

Bachelor Of Science (B.Sc.), Biotechnology

Under Graduation in Biotechnology

Higher Secondary Education, School

Activities and Societies: Chorus, Athletics, Basket ball, Cricket Team. School