QA/QC Manager at Buradon Inc. (2025-01 – 2026-04)
- Conduct training programs for employees, workers, and contract laborers on: Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), FDA requirements, HAZOP and risk assessment, Environment, Health, and Safety (EHS), Personal hygiene and good documentation practices
- Prepare, review, update, and implement SOPs, work instructions, checklists, formats, and quality documents.
- Conduct and manage internal audits, facility inspections, safety audits, and GMP/GLP compliance audits.
- Supervise plant cleanliness, housekeeping, equipment sanitation, personnel hygiene, and cleaning activities.
- Coordinate with the production department to ensure proper line clearance, cleaning verification, process compliance, and batch documentation.
- Manage the testing of raw materials, in-process materials, and finished products through appropriate wet-analysis methods.
- Review laboratory test results, analytical records, logbooks, specifications, and certificates of analysis.
- Coordinate with production and laboratory teams to ensure the quality testing and release of raw materials, packaging materials, in-process materials, and finished products.
- Supervise wet-chemistry analysis, including pH, loss on drying, moisture, titration, assay, identification, specific gravity, heavy metals, and other required tests.
- Maintain the facility in an inspection-ready condition and support regulatory, customer, and third-party audits.
- Prepare quality reports, audit reports, training records, risk assessments, and management-review information.
- Promote compliance with GMP, GLP, FDA, EHS, HAZOP, and data-integrity requirements throughout the organization.
- Monitor plant safety programs, including chemical handling, PPE compliance, emergency preparedness, waste management, fire safety, and risk assessment.
Process Safety Manager at Kaypear Engineering LLP (2024-06 – 2024-12)
- Plan and perform Advanced Reactive System Screening Tool (ARSST) studies to evaluate the thermal and reactive hazards of chemical processes.
- Assess reaction behavior under process-relevant conditions, including exothermicity, self-heating, gas generation, pressure rise, and potential runaway reactions.
- Evaluate reaction and decomposition behavior for raw materials, intermediates, reaction mixtures, and process residues.
- Use ARSST data to identify potential thermal runaway scenarios and critical process conditions.
- Interpret ARSST results together with DSC, TSU, chemical kinetics, and process data to develop a comprehensive reaction safety assessment.
- Provide recommendations for safe operating limits, temperature control, feed rates, cooling requirements, emergency response, and process safeguards.
- Use ARSST results as technical input to HAZOP/PHA studies, process scale-up, SOP development, and process safety reviews.
- Prepare detailed technical reports documenting test conditions, results, interpretation, and process safety recommendations.
- Develop, review, update, and maintain laboratory SOPs and test methods.
- Perform chemical, physical, and analytical testing of raw materials, in-process samples, and finished products.
- Prepare samples, reagents, standards, and solutions required for laboratory testing.
- Operate, calibrate, and maintain laboratory instruments and equipment.
- Record and review test results accurately and maintain complete laboratory documentation.
- Investigate out-of-specification (OOS) or abnormal test results and assist with root-cause investigations.
- Ensure testing is performed according to approved methods, SOPs, and applicable quality requirements.
- Maintain laboratory cleanliness, safety, and chemical inventory.
- Assist with method validation, verification, and troubleshooting when required.
- Communicate test results and laboratory findings to relevant departments.
- Follow all laboratory safety, quality, and regulatory requirements.
QC Chemist at Alembic Pharmaceutical Ltd. (2023-09 – 2023-05)
- Perform analysis using HPLC, GC, GC-MS, IR, and UV-Visible spectroscopy.
- Conduct wet chemical analysis, including: Loss on drying (LOD), pH, Heavy-metal testing, Assay and related chemical tests, Other pharmacopoeial analyses.
- Perform dissolution testing using basket and paddle apparatus.
- Prepare and standardize reference standards, working standards, reagents, and volumetric solutions.
- Carry out daily verification, calibration, and performance checks of laboratory instruments and equipment.
- Review analytical data, calculations, chromatograms, spectra, and test results for accuracy and compliance.
- Follow approved standard operating procedures, analytical methods, specifications, and pharmacopoeial requirements.
- Maintain complete and accurate laboratory records, logbooks, worksheets, and instrument usage records.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results in accordance with established procedures.
- Support method validation, method verification, method transfer, and stability studies.
- Ensure compliance with GMP, GLP, CDSCO, FDA, data-integrity requirements, and applicable pharmacopoeial standards.
- Maintain laboratory cleanliness, safety, and good documentation practices.
- Participate in internal audits, regulatory inspections, and corrective and preventive action activities.
- Strong practical knowledge of pharmaceutical quality-control testing.
- Hands-on experience with HPLC, GC, GC-MS, IR, UV-Visible spectroscopy, dissolution apparatus, and wet analysis.
- Knowledge of instrument operation, calibration, troubleshooting, and preventive maintenance.
- Knowledge of GMP, GLP, CDSCO, FDA, SOPs, data integrity, and laboratory safety.
- Ability to prepare, standardize, label, and store reagents and volumetric solutions correctly.
- Strong attention to detail and accuracy.
QC Chemist Intern at Willowood Chemicals Ltd. (2022-04 – 2022-04)
As a QC Chemistry Intern, assisted in routine analysis of raw materials and crop protection formulations including herbicides, pesticides, and fungicides using HPLC, GC-FID, and UV-Vis spectroscopy, and performed wet chemistry tests such as titration, pH, Karl Fischer moisture, density, and suspensibility to ensure product stability and regulatory alignment.
QC Chemist Intern at Deepak Nitrite Ltd. (2022-08 – 2022-09)
Tested raw materials, in-process samples, and finished products under supervision to ensure compliance with safety, quality, and regulatory standards. Assisted in sample preparation, wet chemical analysis (Titration, cod, bod, pH, KF), and routine lab testing as per GLP/GMP guidelines. Supported senior QC staff in SOP compliance, lab cleaning, and internal audit preparations. Trained on GMP, GLP, FDA, EHS, and laboratory safety protocols.
QC Chemist Intern at Derren Healthcare Pvt. Ltd. (2023-02 – 2023-03)
As a Quality Control Chemistry Intern in a pharmaceutical environment, supported laboratory operations by performing routine testing, preparing samples, and maintaining accurate documentation to ensure product quality and regulatory compliance.
