Analytical thinking
Chintakunta LAXMA REDDY
Quality Control And Quality Assurance
Hyderabad
Summary
Dynamic quality professional with over 13 years of experience in API and OSD formulation divisions, excelling in leading cross-functional teams within Quality Control and Analytical Quality Assurance. Recognized for fostering collaborative teamwork and exceptional communication skills, complemented by strong problem-solving abilities and meticulous attention to detail. Committed to driving operational excellence through the implementation of efficient quality systems that consistently yield outstanding results. Proven track record of enhancing processes to uphold the highest standards of quality and compliance, ensuring organizational success in a competitive landscape.
Overview
13
13
years of professional experience
2
2
Certifications
4
4
Languages
Work History
Section Head - Analytical Quality Assurance
Dr Reddy’s Laboratories Ltd
01.2022 - Current
- Delegated responsibilities effectively across the team, closely monitoring progress, and ensuring timely fulfillment of tasks.
- Maintained audit readiness of the Quality Control Laboratory at all times by proactively identifying and mitigating risks that could lead to critical observations during regulatory, customer, and internal inspections.
- Led and managed regulatory, customer, and internal audits, including laboratory visits and the presentation of Dr. Reddy's quality systems, and drafting of audit responses.
- Identified systemic gaps and implemented new processes or modifications to strengthen compliance and efficiency.
- Conducted root cause investigations for OOS, OOT, deviations, and market complaints, ensuring that corrective and preventive actions were effectively implemented.
- Reviewed and approved protocols and reports for AMV, AMT, monograph evaluations, and hypothesis protocols.
- Evaluated cross-functional team recommendations, and provided final approval for change controls.
- Actively participated in LDM, SDP, and CFT meetings, contributing to problem-solving initiatives, and Lean Six Sigma–driven quality improvements.
- Ensured the timely release of raw materials, intermediates, APIs, and stability samples within defined TAT timelines.
- Oversaw the closure of quality notifications (OOS, OOT, deviations, CCFs, CAPAs) within stipulated timelines.
- Approved pre- and post-qualification of analytical instruments (IQ, OQ, PQ), and reviewed computerized system validation (CSV) documents in the e-Val system.
- Managed working standards, reserve samples, and stability sample tracking in Caliber LIMS.
- Reviewed and approved SOPs, specifications, MOAs, APQRs, and deviation trend reports.
- Authorized backup restoration, verification of analytical instruments, calibration schedules, and preventive maintenance master plans.
- Verified audit trails of chromatographic and standalone systems to ensure data integrity.
- Implemented 5S and Lean Six Sigma methodologies in the Quality Control Lab, driving operational excellence.
- Conducted scheduled Gemba walks, defining, and assigning tasks based on observations.
- Reviewed and approved analytical raw data in Caliber LIMS, including TCI, and MGR approvals.
- Provided training to employees on quality management best practices, fostering a culture of compliance, and excellence.
- Managed and archived quality documentation, ensuring readiness for internal and external audits.
- Updated quality control standards, methods, and procedures to align with evolving compliance requirements.
- Improved QMS efficiency by regularly reviewing and updating procedures in response to business and industry advancements.
- Collaborated with cross-functional teams to enhance production processes, leading to improved product quality.
- Promoted a detail-oriented work culture, encouraging meticulous attention to quality at all stages.
- Led continuous improvement initiatives, actively seeking opportunities for process optimization, and cost reduction.
- Cultivated high-performance organizational culture, aligning employee goals with corporate objectives and rewarding excellence.
Senior Executive Quality Control
Aurobindo Pharma Ltd
09.2018 - 01.2022
- Planned and delegated analysis tasks to team members across shifts, ensuring round-the-clock laboratory operations.
- Reviewed pre-analysis checklists, sample sets, and instrument methods in CDS to ensure readiness.
- Oversaw analytical method transfers (direct or indirect) in line with approved protocols.
- Investigated OOS, OOT, and market compliance samples in Quality Control, ensuring thorough documentation and corrective actions.
- Reviewed and approved analytical raw data in Caliber LIMS, including TCI, and MGR approvals.
- Ensured cleanliness and proper maintenance of analytical instruments and laboratory surroundings.
- Inspected incoming and outgoing materials for accuracy, quality, and compliance with specifications.
- Communicated quality issues to production teams, and collaborated to implement corrective actions.
- Conducted product inspections, evaluating functionality, appearance, and adherence to specifications.
- Improved product quality by identifying defects promptly, and implementing preventive measures.
- Performed root cause analyses on defects, non-conforming products, and customer complaints, driving corrective and preventive actions.
- Reported recurring issues to supervisors, and collaborated with cross-functional teams to resolve systemic problems.
- Conducted visual inspections and non-destructive tests where appropriate.
- Maintained compliance with industry regulations through meticulous record-keeping and documentation of inspection results.
- Reduced product rejection rates by proactively addressing quality issues with production teams.
- Actively participated in team meetings, contributing ideas for process improvements, and efficiency gains.
- Supported and participated in regular audits to verify compliance with industry regulations and company policies, ensuring continued certification and credibility.
Officer Quality Control
Hetero Labs Ltd
07.2016 - 09.2018
- Conducted analytical method verification and method transfers in line with approved protocols.
- Performed analysis of in-process materials, raw materials, finished products, and chromatography-based tests to ensure compliance with quality standards.
- Evaluated working, in-house, and reference standards against pharmacopeia requirements.
- Managed working standards, in-house standards, and reference standards within LIMS for traceability and compliance.
- Prepared protocols, reports, specifications, MOAs, and standard operating procedures (SOPs) to support laboratory operations.
- Ensured scheduled calibration of analytical instruments (daily, monthly, quarterly, and half-yearly) to maintain accuracy and reliability.
- Collaborated with research and development teams to drive innovation in product design, while ensuring strict adherence to industry regulations.
- Managed cross-functional teams, fostering collaboration between departments to improve product development processes, and resolve technical challenges.
- Approved incoming materials by confirming specifications, and performing measurement tests to ensure quality compliance.
PD Lab Officer
Hikal Ltd
04.2015 - 07.2016
- Conducted an analysis of PD Lab samples using chromatographic and non-chromatographic techniques.
- Performed calibration of analytical instruments as per schedule (daily, monthly, quarterly, and semiannually).
- Analyzed protocol-based samples to support investigation and troubleshooting activities.
- Coordinated with vendors for instrument qualification (IQ, OQ, PQ) of new equipment.
- Prepared specifications, MOAs, SOPs, and forms to support laboratory operations and compliance.
- Enhanced laboratory efficiency by implementing new testing procedures and protocols.
- Ensured that quality control measures were consistently followed, maintaining the accuracy and reliability of test results.
- Collaborated with cross-functional teams to troubleshoot complex issues and ensure timely resolution.
- Assisted scientists by collecting, organizing, and reviewing laboratory data.
- Troubleshot and resolved equipment and process-related issues to minimize downtime.
- Developed new protocols and improved existing laboratory processes to strengthen compliance and efficiency.
Executive Quality Control I
Sai Life Sciences Ltd
05.2014 - 04.2015
- Generated AR numbers after receipt of GRNs from the warehouse, and ATRs from the manufacturing team.
- Performed sampling and testing of in-process materials, raw materials, intermediates, and API samples, as per approved procedures.
- Compiled analytical data, prepared reports, and released analytical test results post-analysis.
- Informed supervisors and initiated incident reports for any discrepancies observed during analysis.
- Attended organizational training programs on cGxP, SHE, and other compliance modules to maintain regulatory readiness.
- Maintained a safe working environment by adhering to safety regulations, and ensuring proper handling of hazardous materials.
- Supported continuous improvement initiatives by analyzing data trends and recommending process enhancements.
- Inspected raw materials and finished products to verify quality, disposing of items that did not meet safety requirements.
- Conducted data reviews and applied standard practices to identify solutions for analytical or process issues.
Chemist - Quality Control
Akazem Labs Ltd
08.2012 - 05.2014
- Performed sampling of raw materials, packaging materials, intermediates, and finished products.
- Conducted chemical and physical tests on samples, and released ATRs to the respective departments.
- Ensured calibration of analytical instruments as per schedule (daily, monthly, quarterly, and half-yearly).
- Repaired, calibrated, and safely operated laboratory equipment, reducing costly instrument downtime.
- Streamlined testing procedures to ensure accurate results, while minimizing turnaround time.
- Maintained laboratory efficiency by cleaning, organizing, and keeping supplies well stocked.
- Conducted comprehensive chemical analyses for quality control, ensuring adherence to industry and safety standards.
- I took on additional tasks assigned by the HOD or designee, demonstrating flexibility and accountability.
Education
Master of Science - Organic Chemistry
04.2001 -
Bachelor of Science - Chemistry, Microbiology & Biotechnology
04.2001 -
Skills
Quality management practices
Expertise in validation and method transfer
Regulatory compliance assessment
Cause identification techniques
Skilled in Caliber LIMS and Empower
Expertise in HPLC and GC techniques
Non-chromatographic data analysis
Verification of audit trails
Qualifications evaluation process
Problem-solving investigations
Analyzing quality trends
Validation of GxP computer systems
Certification
Operations Management with Lean Six Sigma from Indian Institute of Management (IIM)-2025, Jammu-India.
Interests
Continuous improvement
Discipline
Timeline
Section Head - Analytical Quality Assurance - Dr Reddy’s Laboratories Ltd
01.2022 - Current
Senior Executive Quality Control - Aurobindo Pharma Ltd
09.2018 - 01.2022
Officer Quality Control - Hetero Labs Ltd
07.2016 - 09.2018
PD Lab Officer - Hikal Ltd
04.2015 - 07.2016
Executive Quality Control I - Sai Life Sciences Ltd
05.2014 - 04.2015
Chemist - Quality Control - Akazem Labs Ltd
08.2012 - 05.2014
Osmania University - Master of Science, Organic Chemistry
04.2001 -
Osmania University - Bachelor of Science, Chemistry, Microbiology & Biotechnology
04.2001 -
Address
Chintakunta Laxma Reddy S/o Chintakunta Bakka Reddy
H No. 2-1-22/94, Sriram Nagar Colony, Kukatpally, Hyderabad-500072, Telangana, India
Declaration
I hereby declare that the information provided in this curriculum vitae is true, complete, and correct to the best of my knowledge and belief.