Quality control leader with proven success in aligning quality procedures with corporate standards and global best practices. Achieves operational improvements through data-driven decision-making and continuous improvement initiatives. Fosters a high-performance culture by mentoring staff and optimising resource management. having 22 years of working experiance in quality opeartionas handling
Hi, I’m
CHANDRESH TIWARI
Mysore
Summary
Overview
20
years of professional experience
Work History
VIBONUM TECHNOLOGIES PRIVATE LIMITED( Althera )Mysore
DIRECTOR – QUALITY CONTROL
03.2023 - Current
Job overview
- Drove company growth by fostering a culture of collaboration and innovation.
- Achieved alignment of team objectives with overarching company goals through effective leadership.
- Conduct thorough assessments of CGMP and GLP practices to meet USFDA, MHRA, and WHO-GMP regulations, ensuring operational excellence and regulatory compliance.
- Managed documentation to ensure compliance with standard operating procedures, specifications, and validation protocols.
- Conducted thorough reviews of testing protocols for raw materials, in-process samples, finished products, and stability studies, utilising analytical techniques and laboratory equipment.
- Maintained compliance with pharmacopeial standards (USP, BP, EP, IP) to uphold product safety and effectiveness.
- Ensure operation qualification, calibration, and maintenance of analytical instruments to uphold accuracy and reliability in testing processes.
- Lead investigations into out-of-specification and out-of-trend deviations to ensure compliance and enhance laboratory safety protocols.
- Coordinated cross-functional teams to address compliance issues and facilitate effective CAPA implementation.
- Ensured compliance with auditing standards through meticulous internal and external audits.
- Delivered actionable insights that improved operational practices and mitigated risks.
- Enhanced stakeholder trust through meticulous audit reporting, ensuring transparency during customer inspections and regulatory authority visits.
- Realised operational excellence by implementing strategies that increased accuracy and accountability.
- Monitor laboratory preparedness using systematic protocols to guarantee audit success and sustained compliance..
- Oversee stability study programs and method verification activities.
- Ensure analytical method transfers comply with ICH guidelines to maintain regulatory integrity.
- Managed quality control personnel by implementing strategic resource allocation practices and providing ongoing training to enhance team capabilities.
- Developed and delivered training programmes on analytical techniques, ensuring data integrity and compliance with industry regulations.
- Achieved significant improvements in analytical methods, leading to enhanced efficiency.
- Delivered successful instrument upgrades that elevated performance metrics.
- Realised cost reductions through strategic initiatives that maximised budget effectiveness..
- Oversee qualification maintenance and utilisation of reference standards, working standards, and reagents to guarantee adherence to laboratory standards and protocols.
- Oversee microbiological analysis and environmental monitoring to ensure compliance with clean room standards.
- Align QC procedures with the best global practices and corporate standards.
- Implemented and maintained LIMS,SAP and JDE Edwards applications for better productivity data integrity compliance.
- Developed and supervised staff by providing orientation, training, support and direction.
- Led team by example to align objectives with overall organisational strategy.
- Managed annual budgeting and financial planning processes, optimising resource allocation and cost control.
- Planned training programme to expand team skills and drive performance.
- Developed successful strategies and policies, meeting organisational needs and implementing improvements.
- Kept organisation in compliance with regulations and internal requirements.
- Managed daily operations by overseeing financials, Key Performance Indicators (KPIs) and employee performance.
- Monitored operations to keep processes aligned with targets and matching forecasts.
- Oversaw recruitment, training, and development of staff, fostering a high-performance organisational culture.
- Controlled expenses and allocated financial resources to reach budget goals.
- Mentored and developed new and existing employees to achieve corporate goals and objectives.
- Determined performance goals, providing crucial feedback on methods to reach milestones.
- Provided technical expertise and guidance on products and applications to meet customers' requirements and needs.
- Reviewed and optimised operational processes, employing best practices to achieve excellence in service delivery.
- Selected and mentored senior staff, creating successful leadership team.
Baxter Pharmaceuticals India Pvt. Ltd.Ahmedabad
Senior Manager – Quality Control
11.2019 - 03.2023
Job overview
- Conduct thorough sampling testing and release processes for raw materials, excipients, and finished products, utilising industry-standard protocols and quality assurance methodologies.
- Utilised risk assessment tools and methodologies to implement quality risk management in alignment with EU GMP requirements.
- Conducted inspections of packed materials and finished products, ensuring compliance with quality control processes and tools.
- Executed customer and regulatory inspections, maintaining compliance with audit frameworks and protocols.
- Oversaw calibration and compliance of laboratory operations to ensure adherence to regulatory standards.
- Developed and implemented a detailed testing programme for various raw and packing materials, utilising industry-standard procedures and equipment.
- Led cross-functional teams in project implementation, achieving timely delivery within budget constraints.
- Led operations team in daily tasks, optimising workflow and increasing efficiency by 20%.
- Reviewed and revised operational policies, aligning procedures with best practices and regulatory requirements.
- Led change management initiatives, guiding teams through transitions with minimal disruption and maintaining high performance levels.
- Investigated issues impacting organisational operations and service delivery to understand root causes, prepare detailed reports and recommend corrective actions.
- Monitored staff performance and developed improvement plans.
- Conducted performance evaluations, identifying areas for improvement and implementing bespoke training programmes.
- Executed JDE Edwards integration at Baxter International to streamline processes and improve user experience.
- Coordinated strategic plans for administrative services management and optimisation to best use available resources.
Medreich Limited
Deputy Manager – QC
03.2017 - 11.2019
Job overview
- Led the sampling, testing, and timely release of raw materials to ensure uninterrupted manufacturing operations.
- Reviewed and updated raw material specifications, ensuring compliance with regulatory requirements and internal quality standards.
- Strengthened material control processes by identifying and addressing compliance gaps in material specifications and testing protocols.
- Updated raw material specifications according to current pharmacopeial monographs (USP, BP, EP, IP) and vendor-specific documentation, maintaining quality assurance.
Wockhardt Ltd.
Senior Executive – QC
10.2015 - 02.2017
Job overview
- Implemented QMS (Quality Management System) to ensure compliance and enhance quality assurance processes.
- Reviewed quality management system data, identifying trends and insights to inform quality improvement strategies.
- Coordinated cross-functional efforts for QMS operations, facilitating collaboration and aligning quality objectives across teams.
- Raw Material Sample Testing & Release.
Sun Pharmaceuticals
Executive – QC
05.2012 - 09.2015
Job overview
- Maintained compliance with internal, customer, and regulatory audit requirements (USFDA, MHRA, WHO-GMP, TGA, etc.) to support operational integrity.
- Verified all test results against specifications to uphold quality standards before releasing finished products and raw materials.
- Identified and reported Out-of-Specification (OOS), Out-of-Trend (OOT), or deviations promptly to ensure product quality.
- 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.
- Perform analytical testing of finished pharmaceutical products as per pharmacopeial standards (USP, BP, EP, IP) and internal specifications.
Ranbaxy Laboratories
Officer – QC
07.2007 - 08.2010
Job overview
- Test pharmaceutical-grade water for microbial contamination and total organic carbon (TOC), ensuring compliance with regulatory standards.
- 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) to validate media performance against pharmacopeial standards.
- Microbiological Testing of API & Raw Materials, Water System & Environmental Monitoring.
- Participate in continuous improvement projects to streamline microbiological processes, aiming to enhance efficiency and reduce testing timelines.
Arbro Pharmaceuticals
Quality Chemist
10.2006 - 06.2007
Job overview
- Performed product testing to verify compliance with quality standards.
- Collaborated with team members to achieve target results.
- Managed complaints with calm, clear communication and problem-solving.
- Maintained clean, safe working environments to eliminate accident risks.
Education
Bundelkhand UniversityUP, India
Master from Biochemistry
2006
University Overview
- [Degree] Graduate
Kanpur UniversityIndia
Bachelor from Science (Chemistry)
University Overview
Skills
- Quality Management Systems (QMS)
- Regulatory Compliance (MHRA, WHO, USFDA)
- Quality assurance
- Quality control standards
- Risk management
- Performance metrics tracking
- Data-driven decision-making
- Continuous improvement
- Change management
- Leadership excellence
- Data integrity
- Regulatory compliance
- Certified Lean SiX Signma Yellow,Green and Blak Belt
- ISO 9001:2015 Lead Auditor
- Total Quality Managemnt
Accomplishments
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
Regulatory Audits
- USFDA Audit
- EMA Audit
- MHRA Audit
- TGA Audit
- WHO-GMP Audit
- ANVISA Audit
- CDSCO Audit
- State FDA Audits
Personal Information
Personal Information
- Title: Director Quality Control
- Date of Birth: 08/07/1982
- Gender: male
- Marital Status: Married
Hobbies and Interests
Hobbies and Interests
- Reading
- Music
- Singing
Disclaimer
Disclaimer
I hereby declare that the information provided is true to the best of my knowledge.Hobbies and Interests
Hobbies and Interests
Driving operational excellence, continuous process improvement, mentoring junior professionals, staying updated on quality standards, problem-solving activities, and wellness programs.
Affiliations
Affiliations
- Recognized with multiple professional excellence awards for consistently delivering critical projects within accelerated timelines, driving cross-functional collaboration, and demonstrating outstanding operational leadership and execution excellence.
- Recipient of several “Star Awards” for exceptional performance, teamwork, and contribution toward organizational goals, operational efficiency, and continuous improvement initiatives.
- Awarded the Certificate of Appreciation by Baxter as “Star Performer of the Year – 2021” for delivering significant impact across Safety, Quality, Delivery, and Cost (SQDC) KPIs, while driving operational excellence and continuous improvement across routine manufacturing and quality operations.
- Recognized for fostering strong cross-functional partnerships and leading high-impact initiatives that enhanced compliance, productivity, quality standards, and business performance.
Timeline
DIRECTOR – QUALITY CONTROL
VIBONUM TECHNOLOGIES PRIVATE LIMITED( Althera )
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
Bundelkhand University
Master from Biochemistry
Kanpur University
Bachelor from Science (Chemistry)