﻿Professional Summary
Over more than thirteen years of leadership and management experience in pharmaceutical , healthcare and life sciences domain with specializing in Quality Management, Quality Engineering, GxP compliance,  ICH (QSEM) Regulatory Affairs compliances, Clinical &amp; Biomedical Research (Phase I – IV), Audits and Training, Project &amp; Operations Management, Business Process Analysis, Software Quality Assurance, Software Development Life Cycle, 21 CFR Part-11 /EU ANNEX 11 compliant Computerized System Validations, GAMP5, Change Control Management validation and   implementation of business applications.
Professionally trained in GXP compliance &amp; applicable regulatory guidelines and accreditation requirements necessary for clinical research organization, clinical &amp; pre-clinical laboratories, medical device, pharmaceutical and healthcare industry established by applicable global &amp; international regulatory authorities. 
Exposure towards implementation of Title 21 Code of Federal Regulations,FDA,  EU Directives (Directive 2001/20/EC), D&amp;C Rules (I), Sch-Y by CDSCO,ICMR Guidelines, , ICH (QSEM), GCDMP, GMP, GLP, GAMP, ISPE, ISMS, clinical safety management  programmes &amp; systems, NABL, CMMi and ISO-quality management systems for pharmaceutical R&amp;D/ CRO/Healthcare establishments.
Hands-on work experience &amp; expertise in BA &amp; BE studies to Phase I to Phase IV clinical studies, including public health studies, involving development and implementation of project-specific &amp; process-specific documentation (SOPs).
Extensive work experience in development, implementation &amp; management of different processes i.e., research operations, project management, audits, quality assurance &amp; quality control, safety reporting &amp; management, data management &amp; analysis, investigator site and ethics committee management, essential document management &amp; documentation controls, computer system validation, vendor management, quality matrices, data confidentiality, systems &amp; specifications development, configuration &amp; change controls and regulatory submissions support.
Extensive working knowledge of GLP, GCP, GMP, GAMP 5 guidelines especially in the areas of GxP critical/specific computerized systems validation or related systems. Led the development &amp; review of GxP/Non-GxP classification, Risk assessment, validation strategy/approach, Validation Master Plan, User Requirement Specifications, Functional Requirements Specification and Requirement Traceability Matrix, Validation Protocols IQ/OQ/PQ documentation, Qualification test Protocols, Test summary report, Validation Protocol, Validation Summary Report, Stage gate assessment reports, SOPs, Protocol Deviation,CAPA, RCA, Decommission report, Periodic Review Report, etc. to ensure they meet FDA, EU and GxP regulations.
Till date successfully achieved GXP Computerized Systems Validation of GMP systems, GLP systems (LIMS,ELN), GCP (CDMS, CTMS, IVRS, IWRS, Safety Management Systems, Regulatory Safety Reporting Systems), IT Infrastructure-cloud, Learning Management Systems, Bespoke-ETL Tool, Global Information Management Systems, spreadsheet validations, system integrations, infrastructure qualification etc.
Excellent Knowledge and implementation experience in GXP compliant Good Documentation Practices &amp; Data Integrity practices. 
Implemented customer service approach for R &amp; D/ healthcare projects and establishment of CRM processes with help of principles of business process modeling and metrics management. Demonstrated capability to quickly gain a detailed understanding of a process in order to optimize efficiencies and improve quality.
Demonstrated experience in implementation of GxP regulations to the aspects of the IT infrastructure and Lab Systems, establishing of GxP compliant QMS for start-ups, realigning &amp; implementation of remediation of GxP compliant processes and systems for established organizations.
Proven expertise in establishment of quality management systems for three clinical research organizations, one site management organization and clinical research departments of two pharmaceutical companies.
Successfully led the team for management of corporate level change control for more than three MNC organizations, and led Infrastructure qualification and certifications for two organizations.
Technical Skills
Sound interpretation &amp; implementation of DCG(I), ICH-QSEM, ICMR, EMEA, WHO and FDA requirements for marketed products &amp; conducting clinical trials and biomedical research for  FDC, NCEs &amp; Medical Devices.
GXP-Quality Management Systems
Policies, SOP, WI , Templates &amp; Manual development
Approaches &amp; Strategies (risk based, metrics based, etc) for 21 CFR Part 11 &amp; EU Annex 11 compliant Computer system validation
Development &amp; technical documentation of CSV Package in compliance with Good Documentation Practice.
Validation implementation phases &amp; respective strategy/approaches (risk-based/ metrics-based) in regulated environment.
Methodologies for Software Development Life cycle (Agile &amp; waterfall) &amp; Software Test Life Cycle in regulated environment.
Risk Management &amp; compliance, Risk/benefit analysis and comparative risk assessments, incl. RiskMap &amp; REMS for GxP critical systems &amp; processes.
Electronic Document /Record Management Systems-Good Documentation Practices &amp; Data Integrity Practices
21 CFR Part 11, Part 820,Part 801, Part 210 &amp; 211
 EU Annex 11, EC 2017/745, EC Reg 2017/746
GAMP V, ITIL v3/v4.
Six Sigma Tools &amp; techniques (FMEA, etc)
Regulatory Gap Assessments &amp; Remediation
Training Need Analysis Clinical Data Management Systems &amp; Electronic data capture tools, including Data Validation and Data Visualization techniques.
SOX controls, SOCII report
SQA activities for life sciences &amp; pharmaceutical domain – Agile &amp; Waterfall model
Audits , Gap Analysis &amp; CAPA
HIPAA, HITECH, GDPR, SAFE HARBOR compliance for IT systems and processes for life sciences.
Clinical Safety Reporting systems
Safety Data, Reports-CSRs, PSURs and SAE Reconciliation
E2b R3 guidelines implementation
Medical Coding Practices
RCA(Root Cause Analysis),
Research Methodology
Project Management methodology (project risk and quality management)
Business Process Modeling
Bench-marking techniques
Analytical Laboratory QMS
RFP &amp; Proposal development
ISO 9001
ISO 13485:2003
ISO 27000 &amp; ISO 27001
ISO 16175
ISO 30301,ISO 30302,ISO 15489, ISO23081, TR1812
ISO 19510
510(K), 21 CFR Part 803-MDR
Drug Product Life Cycle Management
Auditing Skills
Protocol audits &amp; validation
Clinical Study report audit &amp; validation
Essential Document &amp; regulatory dossier audits
GCP Audits ( Inv Site audits)
GLP (Central Laboratory)  audit
GMP audit 
GXP audit 
Clinical Study Document (TMF,SMF, ISF CRFs, etc) audit
Risk Management Systems audits
Regulatory Dossier QC 
Safe Harbor/HIPAA/ Data Privacy  audits 21 CFR Part 11 validation package audits
CDMS &amp; EDMS audits
Contract and Agreements audits
CSR Audits
IT Systems audit
Project Management systems and processes
Surveillance audits
Vendor and Supplier audit
GxP compliant Computer System Validation
Data Integrity (GDP) audits
Supply Chain &amp; Distribution (GDP) audit for IMP
Pharmacovigilance Systems Master File audits
IVRS &amp; IWRS Audits Clinical Safety Management systems &amp; Safety Database audit
IT Skills
OS: Windows/XP.../8/10
Software: MS Office (Access, Excel, Word, Power Point), Adobe Acrobat, MS Project, MS Visio, Crystal Reports, Business Objects, SAS, JIRA.
EDMS: Documentum, SharePoint
DBMS: Oracle Clinical, Medidata, Medrio, Inform
SDMS/LIMS: SQL-LIMS, NuGenesis, Empower CDS
E-Dictionaries: MedDRA, WHO DD, ICD-9/10
Version Control &amp; Testing Tool: IBM Rational Team Concert, HP Quality Centre, JIRA
Testing Skills: Test protocol design, SDLC, Requirements Analysis, Test Plan development and implementation, User Acceptance Testing, Regression Testing, System Testing and Integration Testing.
AERS:  Argus, ARISg
Learning Management Systems: ELVIS, LITMOS.
Professional Summary
Business Analyst (QA) – Apexon (End Client-IQVIA) on IIIrd party contract Sep 2020 Jun 2021
As an approver, ensured SOP &amp; Protocol compliances for Computer Systems Validation deliverables UAT and Validation related GxP Compliant deliverables for IVRS &amp; IWRS (eCOA, ePRO etc).
CSV Engineer – SilverLink Technologies (End Client – Infosys, Novartis)  on IIIrd party contract Aug 2019 Sep 2020
Deliverables:
Contributed as a QA reviewer for the GxP compliant deliverables for GXP projects.
Ensured quality compliance for the pre-release and change control phase for the GxP systems.
Assessed risk related to the systems and analyzes them, if necessary with the Team.
Provided regulatory inputs to project and product management activities/queries.
SPOC for quality, regulatory aspects for GxP project deliverables.
Achievements:
- Actively led EU MDR implementation project.
Lead CSV Consultant-Snyder Technologies  (End Client – ICON CR)  on IIIrd party contract Jan 2018 Nov 2018 
Deliverables:
Contributed as a QA reviewer for the GxP compliant validation packages developed for clinical trial specific ECDMS &amp; Medical Imaging Systems developed on IVRS &amp; IWRS platforms (eCTMS &amp; eCDMS).
Ensured protocol compliance for the clinical databases pre-release and change control phase.
As an approver, ensured SOP &amp; Protocol compliances for Computer Systems Validation deliverables- Project Plan, URS, TM, IQ, PQ, UAT, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report.
Assessed risk related to the systems and analyzes them, if necessary with the Team.
Reviewed and followed SOPs to help the business process in line with applicable FDA &amp; MHRA regulations.
Future Focus InfoTech-Sr. Manager-QA (End Client – TCS, Gilead Lifesciences)  on IIIrd party contract
Jun 2017  - Jan 2018
Deliverables:
Ensured GxP and regulatory compliant validation &amp; testing activities for global GxP application (GIMS: Global Information Management Systems; a single window to cater clinical trial, product complaints, commercial, business development, scientific &amp; pharmacovigilance related queries) for a Big4 pharmaceutical MNC.
Supported and guided the risk analysis of the requirements (functional, business and regulatory) with the Team.
Led efforts for E2B R2 to R3 mapping, conversion and validation.
Responsible for reviewing Test Plans that contain Test Scripts, Test Cases, test data and expected results for respective qualification phases.
Ensured that the Computer System Validation deliverables in compliance with FDA 21 CFR Part11, CFR Part 210 and GLP, GCP, GPP and GMP Compliance Regulations.
GCE Solutions Inc. :  Sr. Manager-QA                                                                                                                  Jan 2015  - Sep 2016
Successfully implemented GXP compliant QMS (Policies, Sops, templates) for drug development services (statistical analysis, biostatistics, CSV, IT infrastructure &amp; project management systems).
Successfully implemented Information Security management program.
Successfully led the new hire induction and periodic training in accordance to established training calendar, and established training record management systems.
Established and validated the enterprise wide cloud based IT infrastructure, i.e. Shared platform–IT infrastructure, Electronic Learning management system, SAS®, IBM RTC, Tableau, Medrio etc. in accordance with GxP and 21CFR Part 11 requirements. 
Acted as CSV-QA resource for driving &amp; implementing GXP compliant validation of IT Infrastructure. Acted as a QA assessor for GXP and study protocol compliance to the awarded clinical trial projects.
Establishment and execution of annual audit plans, performing project deliverable &amp; vendor audits, overall responsible for enterprise-wise training and development. 
Acting as a Quality Assurance designee (SPoC) for project delivery management systems and SLA compliances.
Developed and implemented quality matrices for enterprise-wide status reporting and performance reporting.
Development &amp; implementation of learning management systems, individual Training Plan and assessment. 
Maintenance &amp; overseeing of enterprise-wise inspection readiness. 
Effectively performed root cause analysis and determine corresponding corrective measures. 
Monitored and track all corrective and preventive actions (CAPA) resulting from internal customers, vendors, in process, etc. Actively leading activities for identifying and resolving potential compliance issues
Acted as a principal point of contact for hosting audits and inspections.
Provided technical support to the RFP submission &amp; resolving GxP related business queries.
QA Consultant- Sun Pharma (erstwhile Ranbaxy labs) Jun 2014 -  Jan 2015
Provided support as a validation consultant to the R &amp; D division of a MNC Pharmaceutical Organization for GxP compliant computer system validation for Lab-SDMS, Analytical equipment, Spreadsheets etc.  GxP compliant CSV for LMS, SDMS &amp; Spreadsheets.(Remediation Projects for FDA inspections). 
Successfully led the new hire induction for the group and periodic training as applicable..
Verified, clarified and signed-off of the risk assessment, requirements specification documents, Qualification documents, validation plans, Validation reports, and Traceability Matrix.
Guided &amp; worked extensively with the testing team for designing Test Plan, test scripts, defect management and test reports. 
Played a key role on project issues such as release management, change management, scope control, and requirements prioritization.
Also acted as an evaluator and approver for Change Management Systems for Laboratory systems. 
Addressed GxP GLP, GCP, GMP FDA's CFR part 211, CFR Part 210 approach to compliance issues, and summarized the outstanding problems and issues. 
Communicated the daily operations of the validation team to the management and assured that the master plans, protocols and reports are generated, reviewed and approved within predetermined time lines.
QA Consultant- GCE Solutions Inc Mar 2013 - Jun 2014
Provided technical support and consultancy for setting up &amp; respective validation of Electronic Clinical Data Management Systems for a CRO.
Development of QMS for and successfully completed  validation of statistical tools for a CRO.
Wincere Solutions : Sr. Manager-Quality Assurance Jan 2012 - Jan 2013
Establishment of GxP compliant QMS for clinical research services and IT infrastructure &amp; applications.
Lead the SQA activities for a commercial ETL tool for CDMS
Lead the establishment &amp; performed computer system validation of IT systems for Clinical Portfolio management.
Acted as a QA SPoC &amp; pre-delivery assessor through audits for 15 Clinical (drug development and medical devices) studies.
Implemented SOPs for appropriate quality science techniques and quality management methods in order to enhance operational performance and service quality across the organization. 
Developed and implemented portfolio management system for clinical research services, project/ functional performance management systems, data management &amp; analysis systems, Cloud-based IT infrastructure, vendor relationship management and knowledge management facilitation.
Acted as CSV-QA resource for performing validation of IT Infrastructure 
Development &amp; execution of Audit plans for projects, systems &amp; procedures.
Overall responsible for training &amp; development processes.Successfully led the new hire induction and periodic training in accordance to established training calendar, and established training record management systems.
Established centralised document management systems. Acted as a document controller for learning Management system.
Effectively performed GxP root cause analysis and determine corresponding corrective measures as deviation management. Monitored and track all corrective and preventative actions (CAPA) resulting from clinical trial projects, internal customers, vendors, in process, etc. Actively leading activities for identifying and resolving potential compliance issues.
Provided technical support to the RFP submission &amp; resolving business queries.
Tech Observer India Pvt. Ltd:  Manager-Quality Assurance Oct  2010 - Jul 2011
Established QMS for ISO 9001 certification readiness
Business review of Oracle Clinical DBMS validation. Completed review of validation package for OC DBMS and maintenance of its validated state by performing periodic review and change management systems. 
Delivered QA projects as an individual QA project resource.
Developed &amp; implemented GxP compliant QMS for clinical research services, viz clinical data management, clinical operations, corporate governance, statistical programming, IT infrastructure and clinical quality assurance.
Maintenance of overall organizational Clinical portfolio management systems.
Developed &amp; implemented enterprise-wise training calendar and individual training plan, performed induction and assessment for new hires.Overall responsible for training &amp; development department, and established training record management systems.
Established centralised document management systems. Acted as a document controller for learning Management systems.
Development and execution of audit plans. Acted as pre-delivery assessor for compliant project deliveries for the research operations, biostatistics and data management services to the client.
Provided technical support for submission of RFPs
LG Life Sciences India Pvt Ltd. : Sr. Executive – Quality Assurance Feb  2009 Oct  2010
Developed &amp; implemented QMS (Policies, SOPs, Templates, documentation systems, etc...) for clinical research operations and clinical quality assurance for the R&amp;D division. 
Developed &amp; implemented enterprise-wise training calendar and individual training plan, performed induction and assessment for new hires.Overall responsible for training &amp; development department, and established training record management systems.
Established centralised document management systems. Acted as a document controller for learning Management systems.
Development and execution of audit plans. Performed investigator site audits, vendor audits, essential documents audits, etc
Provided assistance to the regulatory submission activities.
Successfully developed quality metrics for in-sourced processes and systems.
Successfully completed validated change control at corporate level for GMP compliant corporate IP retention systems.
Successfully acted as a QA resource for completion of five end to end clinical studies
Successfully completed Central Laboratory Audits for respective clinical studies
GVK Biosciences Pvt Ltd.: Executive-Quality Assurance Sep  2007 - Feb 2009
Maintenance of Quality Assurance program and systems (SOPs/Templates/documentation systems, etc...) with performance indicators for organizational processes and pharmaceutical research projects.
Maintained 21 CFR part 11 validated states of GXP systems by periodic review and review of change controls.  
Successfully developed quality metrics for projects, processes and systems. 
Acted as pre-delivery assessor for compliant project deliveries for the research operations, biostatistics and data management services to the client.
 Successfully developed quality metrics for in-sourced processes and systems. Monitored development projects in terms of quality management systems.
Actively participated in capacity building and hosting client audits.
Acted as a regional coordinator for Training &amp; Induction processes for INC GVK Bio
Successfully completed the maintenance of QMS as a pre-delivery assessor for the clinical projects by performing audits.
Actively participated in implementation of organizational level change control for validated IT systems.
Academy for Applied Research &amp; Training in Healthcare: Training Coordinator                                                  Jul  2007 - Sep 2007
Performed training need analysis for the applicable training course module. Implemented &amp; imparted training on course module for clinical research training programme.
Induction, delivering and assessing the training programmes as scheduled for the wards.
Designed &amp; developed the course module on regulatory systems &amp; clinical research processes.
Tata Consultancy Services : Clinical Data Coordinator May 2007 - Jul 2007
Performing data entry operations
Drafting of data validation specification and data validation plan
ACE BIOMED : Clinical Research Associate-QC Jan  2006 - Dec  2006
Quality control of the systems, procedures and study documentation. 
Performing calibration &amp; periodic QC of laboratory &amp; study equipments, maintenance of respective records.
Performing clinical studies on the approved treatment protocols. Subject recruitment &amp; database validation. Study Schedule training for the study participants. 
Monitoring &amp; supporting execution of clinical studies.
Academic Credentials
Masters of Science (Clinical Research) from Dr. M. G. R University, Chennai, India in year 2006 with First Class. 
Bachelors of Science (Biochemistry) from Dr. L. Bullaya College, Vishakhapatnam, India (Affiliated to Andhra University) in year 2004 with First Class.
Personal Details
Correspondence Address: 36-D, DDA Flats, Safdarjung Enclave, New Delhi – 110029.
Date of Birth: 04-12 -1979
Father’s Name: Mr. M.S. Prasad
Nationality: Indian
Languages Known: English, Hindi, Marathi, Gujarati and Bengali.
DECLARATION
I hereby declare that the above particulars are true to the best of my knowledge and belief.
Manish Kumar Prasad
Date:



