CHANDRESH TIWARI
Bangalore
Summary
Quality Control professional with extensive experience in formulations and API sectors. Proven expertise in regulatory compliance (MHRA EU GMP, WHO, USFDA), quality systems, and laboratory operations. Adept at leading QC teams, optimizing analytical processes, and ensuring adherence to cGMP standards.
Overview
19
19
years of professional experience
Work History
Director – Quality Control
VIBONUM TECHNOLOGIES PRIVATE LIMITED
03.2023 - Current
- Company Overview: Althera Group of Companies
- Ensure adherence to cGMP, GLP, and regulatory requirements (USFDA, MHRA, WHO-GMP, etc.).
- Oversee documentation, including SOPs, specifications, validation protocols, and reports.
- Supervise and review testing of raw materials, in-process samples, finished products, and stability studies.
- Ensure compliance with pharmacopeial standards (USP, BP, EP, IP).
- Manage operation, qualification, calibration, and maintenance of analytical instruments (HPLC, GC, UV, IR, TOC analyzer, stability chambers, etc.).
- Lead investigations for OOS, OOT, deviations, and laboratory incidents.
- Implement CAPA and ensure timely closure of compliance issue.
- Represent QC during internal/external audits, customer inspections, and regulatory authority visits.
- Maintain laboratory readiness for audits and ensure continuous compliance.
- Oversee stability study programs and method verification activities.
- Ensure analytical method transfers comply with ICH guidelines.
- Manage and mentor QC personnel, ensuring efficient resource allocation.
- Conduct training programs on analytical techniques, data integrity, and compliance.
- Implement analytical method improvements, instrument upgrades, and cost reduction initiatives.
- Ensure timely review of QC test results for batch release decisions.
- Ensure proper qualification, maintenance, and usage of reference standards, working standards, and reagents.
- Oversee microbiological analysis and environmental monitoring for clean room areas.
- Align QC procedures with the best global practices and corporate standards.
- Implement and maintain LIMS, electronic records, and audit trails for data integrity compliance.
- Perform analytical testing and qualification of new raw materials, excipients, and packaging materials.
- Althera Group of Companies
Senior Manager – Quality Control
Baxter Pharmaceuticals India Pvt. Ltd.
11.2019 - 03.2023
- Leading Raw Material, Packing Material, and Finished Product QC.
- Managing Sampling, Testing, and Release of Raw Materials, Excipients, and Finished.
- Implementing Quality Risk Management (QRM) & EU GMP.
- Driving Vendor Qualification and Alternate API Sourcing.
- Leading Customer & Regulatory Inspections with Seamless Audit.
- Overseeing Calibration & Compliance of Laboratory.
- Implementation of JDE Edwards Across Baxter International.
- Implementation of Reduced Testing Program for Raw & Packing Materials.
Deputy Manager – QC
Medreich Limited
03.2017 - 11.2019
- Led the sampling, testing, and timely release of raw materials to ensure uninterrupted manufacturing operations.
- Reviewed and updated raw material specifications to align with the latest regulatory requirements and internal quality standards.
- Regularly updated raw material specifications in accordance with current pharmacopeial monographs (USP, BP, EP, IP) and vendor-specific documentation.
- Strengthened material control processes by proactively identifying and closing compliance gaps in material specifications and testing protocols.
Senior Executive – QC
Wockhardt Ltd.
10.2015 - 02.2017
- QMS (Quality Management System) Implementation.
- Raw Material Sample Testing & Release.
- QMS Data Review & Trending.
- Cross-functional Coordination for QMS operations.
Executive – QC
Sun Pharmaceuticals
05.2012 - 09.2015
- Perform analytical testing of finished pharmaceutical products as per pharmacopeial standards (USP, BP, EP, IP) and internal specifications.
- Conducted assay, dissolution, uniformity of dosage units, related substances, residual solvents, and other critical tests using analytical instruments like HPLC, UV-Vis, FTIR, and GC.
- Identify and report any Out-of-Specification (OOS), Out-of-Trend (OOT), or deviations immediately.
- Ensure that all test results meet specifications before releasing the finished product or raw material.
- Maintain laboratory compliance for internal, customer, and regulatory audits (USFDA, MHRA, WHO-GMP, TGA, etc.).
Officer – QC
Ranbaxy Laboratories
07.2007 - 08.2010
- Microbiological Testing of API & Raw Materials, Water System & Environmental Monitoring.
- Test pharmaceutical-grade water for microbial contamination, and total organic carbon (TOC).
- Execute environmental monitoring (air sampling and settling plates) in production and microbiology testing areas.
- Prepare microbiological media (TSA, SDA, R2A, MSA, MacConkey, etc.) and conduct growth promotion testing (GPT) as per pharmacopeial standards.
- Participate in continuous improvement projects to enhance efficiency, reduce testing timelines, and optimize microbiological processes.
Quality Chemist
Arbro Pharmaceuticals
10.2006 - 06.2007
- Performing the Finish product testing and support to senior analyst.
Education
Master - Biochemistry
Bundelkhand University
Bachelor - Science (Chemistry)
Kanpur University
Skills
- Quality Management Systems (QMS)
- Regulatory Compliance (MHRA, WHO, USFDA)
- Analytical Instrumentation (HPLC, GC, UV-Vis, FTIR)
- Vendor Qualification & Risk Management
- CAPA, OOS & Deviations Handling
- SAP
- JDE Edwards
- LIMS implementation
- Integration
Accomplishments
- Successfully worked on and established fully operational Quality Control and Microbiology laboratories as part of greenfield projects for the Althera Group of Companies (Bangalore and Mysore Unit-1 and Unit-2).
- Led the transition to JDE Edwards ERP for QC data and material management, lab operations.
- Designed and implemented a Reduced Testing Program (RTP) based on supplier performance and historical data.
- Executed multiple cost-cutting initiatives, optimizing analytical workflows, reducing consumables, and improving turnaround times.
- Recognized globally and at site level for outstanding contributions to cost savings and project completions.
Languages
English
Hindi
Regulatory Audits
- USFDA Audit
- EMA Audit
- MHRA Audit
- TGA Audit
- WHO-GMP Audit
- ANVISA Audit
- CDSCO Audit
- State FDA Audits
Personal Information
- Title: Director Quality Control
- Date of Birth: 08/07/1982
- Gender: male
- Marital Status: Married
Hobbies and Interests
- Reading
- Music
- Singing
Disclaimer
I hereby declare that the information provided is true to the best of my knowledge.
Timeline
Director – Quality Control
VIBONUM TECHNOLOGIES PRIVATE LIMITED
03.2023 - Current
Senior Manager – Quality Control
Baxter Pharmaceuticals India Pvt. Ltd.
11.2019 - 03.2023
Deputy Manager – QC
Medreich Limited
03.2017 - 11.2019
Senior Executive – QC
Wockhardt Ltd.
10.2015 - 02.2017
Executive – QC
Sun Pharmaceuticals
05.2012 - 09.2015
Officer – QC
Ranbaxy Laboratories
07.2007 - 08.2010
Quality Chemist
Arbro Pharmaceuticals
10.2006 - 06.2007
Bachelor - Science (Chemistry)
Kanpur University
Master - Biochemistry
Bundelkhand University
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