Summary
Overview
Work History
Education
Competency And Skills
Personal Information
Languages
Timeline
Generic
Illuru Bhaskara Rao

Illuru Bhaskara Rao

Hyderabad

Summary

A creative and enthusiastic pharma professional with 14 years of multifarious experience in CSV and Quality, serving in the areas of various GxP applications of IT, Manufacturing and Quality Systems. Currently working as Lead oversees projects CSV & Compliance Team across Aurobindo Pharma.

Overview

15
15
years of professional experience

Work History

Oversees CSV and Digital QA Lead

Aurobindo Pharma Ltd
12.2020 - Current

Lead Quality and Process Digitalization

Srini Pharmaceutical Limited
06.2018 - 12.2020

Lead Quality Management System and Regulatory Documentation

Hetero Biopharma Limited
06.2017 - 06.2018

Lead Quality and Audit Compliance

MSN Laboratories Limited
03.2015 - 05.2017

Manufacturing Quality System Specialist

Aurobindo Pharma Limited
04.2011 - 02.2015

Quality Assurance Analyst

Cipla Ltd
03.2010 - 03.2011

Education

B. Tech - Biotechnology

Asian Institute of Technology
05.2008

Competency And Skills

  • Leading Oversees Projects Validation and Compliance team to ensure all aspects of activity within the group adhere to required policies and procedures, including safety and training.
  • Development of Validation strategy, Validation Master Plans related to computer systems validation for assigned systems.
  • Develop and review Computer System Validation Artifacts including Validation Master plans, Requirements Specification, Design Specifications, Test Plans (System Test, User Acceptance Test, Installation Qualification), Test Summary Reports (System Test, User Acceptance Test, Installation Qualification), Traceability Matrix, Validation Summary Report, Release for Use Memo, SOP's, Work Instructions.
  • Develops complete understanding of internal and external policies and procedures related to all aspects of computer system validation and its Compliance.
  • Ensure that the validation artifacts meet the quality requirements and applicable regulations FDA (Food and Drug Administration), EU, Corporate & International Standards.
  • Participate in Validation Cross Functional Teams at corporate and sites (Worldwide) to ensure adherence to required policies and procedures.
  • Liaises with cross-functional SMEs (Subject Matter Experts) in developing and promulgating the computer system validation methodology.
  • Pre-approve and post-approve validation documentation and assessments from a quality perspective.
  • Provides CSV as well as CSA expertise and guidance related to management, peers, and lower-level professionals.
  • Participate in the Change Management process ensuring that all changes to validated computer systems are effectively assessed to ensure regulatory compliance is always maintained.
  • Lead the area Validation team in preparation for regulatory, internal, and corporate audits and inspections.
  • Represent as an Internal Auditor for Computerised System and IT System for audits across the organisation.
  • Report out Associate President on Validation status and metrics. Keep abreast of changing regulatory requirements, standards, and guidelines.
  • Instrumental in Regulatory, Serialisation, Quality Assurance, Quality Control, Manufacturing and CSV (Computer System Validations) skills and to take up regulatory challenges in Regulatory Industries including 21 CFR Part 11 and Annexure11 Compliance and computer system validation activities, regulatory audits, contributing to the organization goals, to achieve career advancement of self-consistence with the growth of the organization.
  • Excellent track record in effectively and efficiently managing global (multi-shore) sites for large and complex engagements.
  • Specialized in Delivery / Program experience in managing various multi-million-dollar Validation projects.
  • Participates in depth into project design and solutions. Contributes to the overall project/program plans, schedule, milestone wise deliverables and validates business requirements vs solutions.
  • Expert in review and approval of validation deliverables (MVP, GxP Assessment, VP, URS, FS, FRA and SRA, IQ/OQ/PQ qualification documents, 21 CFR Part 11/EU Annexure 11 Compliance Report, traceability Matrix and validation summary) of various GxP applications as per the GAMP5 guidelines.
  • Expert in review of periodic review reports, appropriate CAPA implementations and Audit compliance Reports of various GxP applications.
  • Rich experience in Review of change control procedures for various GxP applications to maintain validated status.
  • Proven track-record of managing a portfolio of large and/or complex IT programs, preferably in the Life Sciences domain.
  • Demonstrated ability to manage multiple, simultaneous projects and programs.
  • Experience in pharmaceutical industry and an understanding of Quality Assurance, manufacturing, Laboratory and Regulatory Compliance.
  • Proven ability to apply depth of expertise across multiple related disciplines and integration points with other functions.
  • Resolving complex or unusual business problems, typically involving the innovation of new solutions.
  • A strong background in computerized system validation like DMS(Caliber),QAMS (Caliber) LIMS(Caliber) and Manufacturing Execution Systems (eBR).
  • Strong knowledge of regulatory validation requirements including FDA, EMA, and all other Worldwide Regulatory requirements.
  • Relevant experience with data integrity requirements and implementation in a GMP environment.
  • Knowledge of Quality principles, computer system development lifecycles, GAMP 5 Methodology, 21 CFR Part 11 and EU Annexure 11 guidelines and Data Governance System.
  • Knowledge of SOPs, cGMP’s and compliance requirements and regulatory guidelines and the technical acumen to work and manage within a regulatory environment.
  • Knowledge of Software Development Lifecycle (SDLC) like Agile, Waterfall and V Model and have working knowledge of the PMI Project Management Body of Knowledge (PMBOK).
  • Problem solving ability and excellent oral and written communications skills.
  • Experience dealing with regulatory agencies and global audit teams.
  • Excellent communication skills and ability to influence others.

Personal Information

  • Date of Birth: 06/10/84
  • Marital Status: Married

Languages

English
Advanced (C1)
Hindi
Intermediate (B1)
Telugu
Advanced (C1)

Timeline

Oversees CSV and Digital QA Lead

Aurobindo Pharma Ltd
12.2020 - Current

Lead Quality and Process Digitalization

Srini Pharmaceutical Limited
06.2018 - 12.2020

Lead Quality Management System and Regulatory Documentation

Hetero Biopharma Limited
06.2017 - 06.2018

Lead Quality and Audit Compliance

MSN Laboratories Limited
03.2015 - 05.2017

Manufacturing Quality System Specialist

Aurobindo Pharma Limited
04.2011 - 02.2015

Quality Assurance Analyst

Cipla Ltd
03.2010 - 03.2011

B. Tech - Biotechnology

Asian Institute of Technology
Illuru Bhaskara Rao