Risk Assessment System Validation
Resume:
RAGHUNATH CHIDRAWAR
CSV-Consultant
+919********* *************@*****.*** Hyderabad, Pune
SUMMARY
Overall 13 years of experience in different domain of pharma and currently working as Validation Consultant in Computer System Validation (CSV) with 6 years of experience, adept at leading validation activities and ensuring compliance with 21 CFR Part 11 and EU Annex 11 guidelines. Skilled in risk assessment, test management, Defect Management and GAMP 5 principles. Enthusiastic about contributing to innovative projects and fostering a culture of excellence in line with industry standards.
EXPERIENCE
Validation Consultant
Rephine India Ltd
07/2023 Hyderabad
Lead for validation activities of GxP and non-GxP systems across the SDLC including URS, FS, Risk Assessment, Test Plans, Protocols, Summary Reports for Trackwise project.
Involved in CSV delievarable for SAP System as Validation Reviewer Developed and implemented validation strategy, plans and CSV governance framework for QMS System act as System Analyst role. Working as a system admin for Valgenesis tool implemented in organization.
Mentored junior team members in best practices related to validation activities, fostering a culture of continuous improvement within the organization.
Reduced human error in testing by imlementing manual validation statergies.
Sr. Validation Analyst
Birlasoft Ltd
09/2021 - 07/2023 Pune
Worked on AIML Automation and functioned as System validation analyst.
Developed and implemented validation strategy, plans and CSV governance framework for PV process automation projects act as Validation analyst.
Interact with stakeholders for requirements gathering and communicating validation status
Experience working with tools like JIRA, QTEST and HPALM, etc. Collaborated with cross-functional teams to ensure consistent application of validation standards across projects. Monitored resolution of bugs, tested fixes, and helped developers tackle ongoing problems by providing QA perspective. Reduced human error in testing by implementing automated validation systems and tools
Recommended changes and corrections to developers for optimal software performance and usability.
SKILLS
Computer System Validation
21 CFR Part 11 and EU Annex 11
Test management GAMP 5
Risk Assessment Change Control
CAPA Agile Waterfall
Data Integrity Audit process
ACHIEVEMENTS
Key achievements include developing and
implementing validation strategies,
mentoring junior team members, and
reducing human errors in testing through
automation.
Seeking a Validation Consultant position at
a company that values quality and
compliance, where I can leverage my skills
to support the company's mission of
maintaining industry best practices and
data integrity.
INDUSTRY EXPERTISE
CSV and Comapliance
Validation and Defect Management
Audit and Risk Assessment
LANGUAGES
Enslish
Proficient
Hindi
Native
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EXPERIENCE
Validation Specialist
Mindtree Ltd
01/2021 - 08/2021 Bangaluru
Responsible for end-to-end CSV process as per client SOP's. Responsible for review and approve lifecycle documentation for CSV by maintaining the quality and security standards in Trackwise system.
Validate the Deliverables for each phase of the SDLC to ensure the quality of the deliverables.
Conducted thorough root cause analyses to address deviations during validation activities, implementing corrective actions as needed..
Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11 and EU GMP Annex 15.
Proposed development and testing improvements to positively impact usability, function and performance.
R&D officer
JB Chemicals and Pharmaceutical
07/2013 - 06/2014 Mumbai, India
Involved in Preparation of RMS, FPS and Stability data planning for formulations.
Worked on Stability, OOS, User management, Column Management, Raw material inventory modules of Caliber LIMS.
Performed stability studies for OSD and injectable formulations as per ICH and WHO guideline.
Mentored junior scientists, developing their technical skills and professional competencies for long-term success.
Conducted root cause analysis to identify opportunities for improvements in manufacturing processes, leading to better overall product quality.
Regulatory Affairs officer
BDH Industries Ltd
05/2012 - 07/2013 Mumbai, India
Submission of registration dossiers to DRA in compliance with the country's guidelines.
Involved in documentation and approval of COPP and WHO GMP Certification from CDSCO India for company products application. Involved in preparation of dossiers in CTD format and track regulatory documentation.
Involved in documentation and approval of COPP and WHO GMP Certification from CDSCO India for company products application Trainee Chemist – Apprentice.
AnaZeal Analyticals & Research Pvt
09/2011 - 04/2012 Mumbai
Involved in analytical method development, Validation for Assay, dissolution of tablets by UV and HPLC system
LANGUAGES
German
Beginner
EDUCATION
M. Pharmacy- Pharmaceutical
Chemistry
School of Pharmacy, SRTM University
07/2009 - 07/2011 Nanded
AWARDS
Cognizant management rewared 4 times
for Quality work and different ideation in
project optimisation and cost saving
activities.
CERTIFICATION
Basic Lean Six Sigma certificate
Awarded for completion of Data Quality and
Compliance project by cognizant.
QTest Analyst
Certified by QA Symphony on completion of
training for Analyst Role
JIRA Project Analyst
Certified by Atlassian on completion of training
of Agile Management course
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