Nagaraju Akinapally
Hyderabad
Summary
Dynamic clinical operations leader with extensive experience at Dr. Reddy's Laboratories, excelling in regulatory compliance and quality assurance. Proven track record in executing risk-based vendor qualifications and multi-domain audits, ensuring data integrity and operational excellence. Adept at team collaboration and training development, driving successful clinical trials across diverse therapeutic areas.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Manager-Clinical Quality Assurance
Dr.Reddy's Laboratories Limited
08.2017 - Current
- Execution of Risk-Based Vendor Qualifications across USA, Europe, Middle East, and Asia Pacific CROs, Clinical Trial Vendors, Pre-Clinical vendors, Immunogenicity vendors, and Pharmacovigilance (PV) vendors, ensuring alignment with USFDA, EMA, ICH, and CDSCO regulations.
- Execution, Follow-up and Closure of Study-Specific Audits, including: Project Management & TMF Audits, Central Lab & Data Management Audits, Clinical Study Report (CSR) Audits, Investigator Site Audits, For-Cause & Investigation Audits, Packaging & Labeling Vendor Audits, Pharmacovigilance Audits.
- Strategic Execution, Follow-up and Closure of multi-domain audits to uphold compliance, data integrity, and operational excellence in clinical research Including: Phase I, II, III, 505(b)2, Pre-Clinical, and Immunogenicity studies, Computer System Validation (CSV) Lifecycle Audits (EDC, CTMS, LIMS, LMS and ELN), Led CSV audits to verify compliance with FDA, EMA, ICH, and GAMP 5 guidelines, ensuring data integrity and system reliability, Oversaw Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to validate system functionality, Ensured adherence to 21 CFR Part 11 for electronic records and signatures, maintaining regulatory compliance.
- Implementation of Integrated Quality Management System across domains: Maintained Standard Operating Procedures (SOPs) and implemented Quality Assurance Programs to uphold regulatory compliance, Implemented Quality Assurance Programs to ensure system readiness and regulatory compliance, Conducted inspection readiness assessments to verify adherence to industry standards and regulatory requirements, Managed training assignments, completions, and compliance tracking for Global Clinical Management team (USA, India and Russia) and Clinical QA personnel, Oversaw uploading and maintenance of SOPs, protocols, and regulatory documents within LMS, Execution of Internal audits, Governance and Execution of Change Controls, Incidents & Deviations, CAPA Management, Process Optimization, Technology Integration.
Manager-Clinical Operations
Dr.Reddy's Laboratories Limited
10.2013 - 08.2017
- Led the execution of clinical studies across Phase II, III, PMS, and Patient PK Studies, ensuring compliance with ICH/GCP, FDA, EMA, and CDSCO regulations.
- Managed multicenter clinical trials through CRO collaborations, overseeing site selection, initiation, monitoring, and close-out activities.
- Directed the preparation and review of essential clinical documents, including Protocols, Study Plans, Informed Consent Forms, IMP Labels, Monitoring & Audit Plans, Risk Mitigation Strategies, Case Report Forms, and site close-out reports.
- Collaborated with global teams and external stakeholders, including vendors, regulatory bodies, licensing partners, and pharmaceutical peers, to drive study success.
- Provided inspection readiness support, ensuring compliance.
- Developed and executed training programs to enhance organizational focus on quality, data integrity, and regulatory compliance.
Assistant Manager-Clinical Quality Assurance
Dr.Reddy's Laboratories Limited
07.2011 - 10.2013
- Led Risk-Based Vendor Qualifications and executed audits across India for CROs (BA/BE, Pre-Clinical), ensuring alignment with USFDA, EMA, ANVISA, ICH, and CDSCO regulations.
- Conducted multi-domain audits to uphold compliance, data integrity, and operational excellence in clinical research across Phase I (BA/BE), Pre-Clinical studies.
- Managed Study-Specific Audits, including Clinical Study audits & Bioanalytical audits: Project Management & TMF Audits, Central Lab & Data Management Audits, Clinical Study Report (CSR) Audits, For-Cause & Investigation Audits, Packaging & Labeling Vendor Audits.
- Implementation of Integrated Quality Management System across domains: Maintained Standard Operating Procedures (SOPs) and implemented Quality Assurance Programs to uphold regulatory compliance, Implemented Quality Assurance Programs to ensure system readiness and regulatory compliance, Conducted inspection readiness assessments to verify adherence to industry standards and regulatory requirements, Execution of Internal audits, Governance and Execution of Change Controls, Incidents & Deviations, CAPA Management.
Research Associate-Clinical
Aragen Life Sciences(GVK Biosciences Private Limited)
01.2007 - 01.2011
- Prepare and review Standard Operating Procedures (SOPs), Protocols, and Clinical Study Reports.
- Successfully conducted and oversaw the execution of Clinical Pharmacology studies, contributing to the delivery of over 100 clinical trials across diverse therapeutic areas and study phases.
- Lead activities such as Site Identification, Selection, Initiation, Monitoring, and Close-out processes.
- Managed the uploading of required documentation into the Clinical Trial Management System (CTMS).
- Provided support during Regulatory inspections, Sponsor audits, third-party audits, and Quality Assurance evaluations.
- Addressed/ resolved bio-deficiencies raised by regulatory agencies.
- Guided and provided training to subordinates protocol adherence and clinical trial methodologies for study execution.
Education
Master of Business Administration - Human Resources
Andhra University
Visakhapatnam, Andhra Pradesh07.2025
Master of Pharmacy - Pharmacology
Rajiv Gandhi University of Health Sciences
Bengaluru, Karnataka01.2007
Bachelor of Pharmacy - Pharmacy
Kakatiya University
Warangal, Telangana01.2004
Diploma in Pharmacy - Pharmacy
State Board of Technical Education & Training
Hyderabad, Telangana01.2000
Skills
- Regulatory Compliance
- Risk Management
- ICH
- GCP
- Quality assurance
- FDA
- EMA
- GxP auditing
- Capa management
- Inspection readiness
- Leadership
- Continuous improvement
- Clinical Research
- Patient Pharmacokinetic studies
- Phase III trials
- GCP audits
- Clinical research software applications
- Electronic Data Capture (EDC)
- Learning management systems (LMS)
- Laboratory information management systems (LIMS)
- SAP
- Lotus Notes
- Immunogenicity
- Quality management systems (QMS)
- Auditing
- Inspection handling
- Nonclinical systems
- Clinical systems
- Pharmacovigilance systems
- Good Clinical Practice (GCP)
- Good Pharmacovigilance Practice (GPV)
- Clinical trial methodologies
- Investigational Medicinal Product (IMP) management
- Project management
- Vendor negotiation
- Data integrity
- Risk assessment
- Regulatory compliance
- Clinical research
- Team collaboration
- Training development
- Vendor management
- Operations management
- Documentation and reporting
- Decision-making
- Staff training and development
- Complex Problem-solving
- Cross-functional team management
- Performance management
- Cross-functional teamwork
- Goal setting
- Employee onboarding
- Team leadership
- Recruiting and interviewing
- Risk management
- Workforce management
- Partnership development
- Work prioritization
- Employee training
- Brand management
- Change management
- Staff development
- Schedule preparation
- Shift scheduling
Accomplishments
- International Paper, Analgesic, Anti-Inflammatory and Antiarthritic Activity of Newly Synthesized Bicyclothieno 1, 2, 3 - Triazines, Macedonian Journal of Medical Sciences, 06/15/11
- International Paper, AUTISM - A Neurological Disorder in Children, Pharmacologyonline, 2009
- National Paper, Analgesic and anti-inflammatory activity of Bicyclo thieno 1, 2, 3- triazines in mice, 12th APTI 2007, 10/25/07
Visa Information
USA (B1/B2 validity till 2029)
Personal Details
- Father's Name: Venkateshwarlu
- Notice Period: 3 Months
- Date of Birth: 07/11/81
- Marital Status: Married
Certification
- Good Clinical Practice (GCP)
Languages
Telugu
First Language
English
Proficient (C2)
C2
Hindi
Advanced (C1)
C1
kannada
Intermediate (B1)
B1
Timeline
Manager-Clinical Quality Assurance
Dr.Reddy's Laboratories Limited
08.2017 - Current
Manager-Clinical Operations
Dr.Reddy's Laboratories Limited
10.2013 - 08.2017
Assistant Manager-Clinical Quality Assurance
Dr.Reddy's Laboratories Limited
07.2011 - 10.2013
Research Associate-Clinical
Aragen Life Sciences(GVK Biosciences Private Limited)
01.2007 - 01.2011
Master of Business Administration - Human Resources
Andhra University
Master of Pharmacy - Pharmacology
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - Pharmacy
Kakatiya University
Diploma in Pharmacy - Pharmacy
State Board of Technical Education & Training
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