Venkata Chandrasekhar D
Hyderabad
Summary
Experienced Quality & Compliance Professional with a strong background in R&D operations, specializing in the review and oversight of GxP documentation including procedures, non-conformances, change controls, investigations, CAPAs, validation protocols/reports, and technical justifications. Proven ability to lead compliance risk identification, ensure adherence to quality agreements, and support regulatory readiness through meticulous document review and process improvement. Adept at coaching and training teams to build quality culture and ensure continuous compliance with evolving regulatory standards and global quality systems.
Overview
13
13
years of professional experience
Work History
Assistant Manager
Biological E. Ltd| Analytical Quality Assurance
Hyderabad
04.2022 - Current
- Reviewed and approved elements of Quality Management System, including change controls and CAPA investigations.
- Led R&D and commercial Quality & Compliance functions, ensuring product quality and compliance with global standards.
- Executed supplier qualification and ongoing monitoring for adherence to regulations and specifications.
- Coordinated internal and supplier audits, maintaining quality agreements with partners.
- Evaluated and integrated new technologies to optimize quality assurance workflows.
- Reviewed analytical method validation protocols, ensuring data integration into quality systems.
- Oversaw stability protocol reviews, trend analyses, and hold-time studies for product stability assessments.
- Collaborated with Regulatory Affairs on quality system strategies and continuous improvement initiatives.
- Review of EMP, NVPC, and water trends.
- Review and approval of microbiology test validation protocols and reports.
- Audit Trail Review of Standalone and Empower Connecting System as per Schedule.
- The internal and external lead auditor roles were handled.
Senior Executive
MSN Laboratories|Analytical Quality Assurance
Hyderabad
12.2021 - 03.2022
- Evaluated stability protocols and data to ensure product shelf-life compliance with regulatory standards.
- Reviewed documentation for in-process samples, hold-time studies, and finished product stability reports.
- Assessed Certificates of Analysis (CoAs) for raw materials and products for specification compliance.
- Monitored purified water system records and conducted periodic evaluations through trend reporting.
- Reviewed analytical method validation protocols, raw data, and final reports for regulatory alignment.
- Led audit trials related to QC instrumentation, ensuring readiness for regulatory audits.
- Reviewed change control documents and incident reports for compliance with Quality Management System.
- Conducting GLP trainings.
Senior Executive
Aurobindo pharma Pvt Ltd|Analytical Quality Assurance
Hyderabad
05.2019 - 11.2021
- Reviewed and closed key quality documents, ensuring compliance with global QMS standards.
- Proactively addressed operational quality issues to prevent recurrence of incidents.
- Collaborated with complaints team to assess product complaint reports and ensure feedback resolution.
- Ensured data integrity and compliance with 21 CFR Part 11 during document review processes.
- Supported batch disposition and lot release; reviewed analytical data for various testing phases in LIMS.
- Prepared and approved SOPs and GMP/GDP documents to maintain compliance with regulatory standards.
- Partnered with Compliance and Regulatory Affairs teams to implement QMS strategies for continuous improvement.
- Maintained audit readiness by hosting internal audits and tracking timely CAPA closures.
- System and Batch Audit Trail Review and Compliance.
- Conducting GLP trainings.
Officer
Mylan Laboratories Pvt Ltd| Quality Control
Hyderabad
11.2016 - 05.2019
- Conducted stability study analysis for finished products and intermediates.
- Reviewed stability protocols, reports, and summaries to ensure compliance.
- Performed internal reference standard analysis to validate results.
- Operated HPLC, KF, GC, UV, and IR spectroscopy equipment effectively.
- Audit Trails Review and Compliance as part of Batch Release.
- Prepared Certificates of Analysis for commercial products.
- Supported regulatory audits by USFDA, ANVISA, EU, GMP, CDSCO, and customers.
- Investigated Out of Specification (OOS), Out of Trend (OOT) deviations, incidents, and managed CAPA processes.
Team Member
Dr. Reddys Laboratories Pvt Ltd|Quality Control
Hyderabad
07.2014 - 11.2016
- Handled wet analysis for intermediate and finished product analysis.
- Handled various analytical instruments, including HPLC, GC, UV, IR, KF, and conductivity meter.
- Performed raw material sampling and thorough analysis to ensure quality standards.
- Prepared Certificates of Analysis (COA) and managed batch release activities.
- Calibrated analytical instruments to maintain accuracy and reliability.
- Executed water sampling and analysis to guarantee compliance with specifications.
QC Chemist
Virupaksha Organics Pvt Limited
Hyderabad
04.2012 - 06.2014
- Conducted raw material sampling and analysis to ensure quality standards.
- Managed calibration of analytical QC instruments including HPLC, GC, KF, UV, IR, pH, and conductivity meter.
- Performed in-process checks from initiation to completion for accurate analysis approval.
- Prepared Certificates of Analysis (COA) and facilitated batch release activities.
Education
M.SC - Organic chemistry
JNTU Campus
B.SC - Biotech, Micro biology
SVU
Skills
- Successfully handled Regulatory Audits of (USFDA, EU GMP, WHO, ANVISA, MHRA, Health Canada, NABL, CDSCO, SAPHRA)
- Customer Audits
Software Exposure
- SAP, Track Wise, Agile, LIMS, LMS, DMS, Empower-3, and Lab Solutions
- Windows, MS Word, MS Excel, MS PowerPoint, and Internet applications
- PGDCA (Post Graduate Diploma in Computer Applications)
Languages
- Telugu
- English
- Hindi
Skills
- Self-confidence
- Eagerness to learn
- Leadership ability
- Deadline management
- Communication skills
- Public relations expertise
- Interpersonal skills
- Strong work ethic
- Quick learner
- Adaptability to change
- Problem-solving skills
- Verbal communication
- Written communication
- Willingness to learn and grow
- Resourceful time management
Disclaimer
- I hereby declare that the information furnished above is true to the best of my knowledge.
Timeline
Assistant Manager
Biological E. Ltd| Analytical Quality Assurance
04.2022 - Current
Senior Executive
MSN Laboratories|Analytical Quality Assurance
12.2021 - 03.2022
Senior Executive
Aurobindo pharma Pvt Ltd|Analytical Quality Assurance
05.2019 - 11.2021
Officer
Mylan Laboratories Pvt Ltd| Quality Control
11.2016 - 05.2019
Team Member
Dr. Reddys Laboratories Pvt Ltd|Quality Control
07.2014 - 11.2016
QC Chemist
Virupaksha Organics Pvt Limited
04.2012 - 06.2014
M.SC - Organic chemistry
JNTU Campus
B.SC - Biotech, Micro biology
SVU
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