Jatinder Kapoor
Brampton,Canada
Summary
Pharmaceutical industry professional with high Caliber experience in quality & compliance, quality investigations management. Extensive experience of working with reputable global pharmaceutical & life science companies, internalizing, and deploying industry best practices to deliver operational excellence. Proactive, achievement driven professional with robust work ethic, impeccable integrity, and excellent communication, influencing, problem solving, decision making and planning experience in quality and inspection according to standards. Dedicated and knowledgeable Quality Assurance Specialist with leadership and training experience. Delivers in-depth competencies within cGMP, GMP, FDA regulated environments.
Scientist with strong foundation in chemical analysis, research methodologies, and laboratory management. Skilled in conducting complex experiments, optimizing processes, and ensuring quality control. Known for collaborative approach, adaptability to shifting priorities, and results-driven mindset. Consistently leverages expertise in spectroscopy, chromatography, and data interpretation to drive impactful outcomes.
Overview
18
18
years of professional experience
Work History
Senior Chemist
Unilab Analytical Services Inc.
04.2024 - Current
- Preparing IQ/OQ/PQ Protocol.
- Qualification of Instrument
- Validation of Computerized systems associated with Instrument.
- Calibration of Instrument.
- Maintenance of Instrument
- Conducted routine quality control tests to ensure compliance with industry standards.
- Documented test results accurately, maintaining meticulous records for regulatory compliance.
- Collaborated with team members to troubleshoot analytical methods and improve testing procedures.
- Assisted in the development of standard operating procedures for laboratory processes.
- Implemented corrective actions in response to non-conformance issues identified during testing.
- Trained junior staff on proper laboratory techniques and safety protocols.
- Analyzed chemical samples using advanced laboratory techniques and instrumentation.
- Reviewed and verified data integrity, ensuring reliability of results reported to clients.
- Assisted in the development of new products by conducting feasibility studies, stability tests, and compatibility assessments.
- Prepared and standardized test equipment, test solutions and reagents to enable successful testing completion.
- Operated specialized scientific equipment and performed complex procedures to execute high-level analytical testing tasks.
- Served as subject matter expert on chemistry-related topics during audits or customer visits, demonstrating company''s commitment to excellence in quality control practices.
- Advised chemists and laboratory technicians on existing and emerging quality control methods to enhance testing and research capabilities.
- Generated technical reports and other documentation to record analytical test results and conclusions.
- Maintained a safe working environment by adhering to strict safety protocols and conducting regular inspections of equipment and facilities.
Quality Control Manager
Universal Analytical Lab Inc.
07.2021 - 03.2024
- Preparing IQ/OQ/PQ Protocol.
- Qualification of Instrument
- Validation of Computerized systems associated with Instrument.
- Calibration of Instrument.
- Maintenance of Instrument
- Led team in conducting regular inspections to identify non-conformance and improve product quality.
- Developed and implemented quality control procedures to ensure compliance with industry standards.
- Trained staff on quality assurance protocols, fostering a culture of continuous improvement within the lab.
- Analyzed test results and provided recommendations for corrective actions to enhance operational efficiency.
- Collaborated with cross-functional teams to streamline processes and reduce turnaround times for testing services.
- Established key performance indicators (KPIs) to monitor quality metrics and drive accountability among team members.
- Conducted root cause analyses on quality issues, implementing strategic solutions to prevent recurrence.
- Managed documentation related to quality control processes, ensuring accuracy and compliance with regulatory requirements.
- Followed quality standards and procedures to minimize errors and maximize customer satisfaction.
- Collaborated with cross-functional teams to identify potential areas of improvement in production processes, leading to enhanced product quality.
- Spearheaded root cause analysis investigations when needed, determining underlying issues and recommending appropriate fixes.
- Participated in regular management review meetings, providing updates on quality control performance and suggesting areas for improvement.
- Improved customer satisfaction with thorough final product inspections and adherence to strict quality control guidelines.
- Updated quality control standards, methods, and procedures to meet compliance requirements.
- Conducted regular audits of production facilities, ensuring compliance with industry standards and regulations.
- Enhanced product quality by implementing rigorous inspection procedures and standardized testing protocols.
- Implemented data-driven decision-making strategies, enabling more accurate identification of trends and areas for improvement.
- Coordinated with other departments to establish preventive maintenance schedules for equipment, reducing downtime due to unexpected failures or malfunctions.
- Managed supplier relationships to ensure high-quality raw materials were consistently used in production processes.
- Streamlined quality control processes, resulting in increased efficiency and reduced costs.
- Used LIMS to produce reports regarding daily production quality, nonconformance of products or processes and quality trends.
- Established a system for tracking non-conformances, facilitating quick resolution and preventing future occurrences.
- Developed comprehensive training programs for new quality control team members, ensuring consistent performance across the board.
- Consistently maintained detailed records of all quality control activities for easy reference during audits or process evaluations.
- Initiated cross-departmental collaborations to integrate quality control measures seamlessly.
- Implemented sustainable quality control practices, contributing to company's environmental responsibility goals.
- Facilitated proactive approach to quality control, preemptively identifying potential issues.
- Optimized testing methodologies to cover broader range of defects with quicker detection times.
- Conducted regular training sessions for staff to uphold and exceed quality standards.
- Led team of quality control specialists, fostering culture of continuous improvement.
- Reduced turnaround time for quality concerns by establishing efficient communication channels between departments.
- Guided organization through several successful quality certification processes, showcasing commitment to excellence.
- Improved product reliability, conducting thorough testing and analysis on each batch.
- Enhanced product quality by implementing rigorous control checks throughout manufacturing process.
- Established and tracked quality department goals and objectives.
- Tracked quality issues with external customers, suppliers, and internal plant operations.
- Inspected products and worker progress throughout production.
- Implemented new quality assurance and customer service standards.
- Monitored staff organization and suggested improvements to daily functionality.
Quality Control team lead
Canadian Analytical Laboratories Inc.
05.2016 - 07.2021
- Testing of raw materials, packaging material, in-process finished and stability sample by HPLC, HPTLC, ICP, GC Column Chromatography, FTIR, UV/Vis spectrophotometer, Auto titrator, Polarimetry ICPMS and other analytical instruments as per GLP, GMP, FDA, Health Canada, ICH guidelines.
- Calibration, Validation and Qualification (IQ, OQ, PQ) of laboratory analytical instruments such as IR, UV, Analytical Balances, HPLC, GC, HPTLC, Polarimeter, , ICP.
- Perform all functions concerning the generation (authoring), management and maintenance of all types of GxP documents generated by the company, as well as performing the required training on new and / or updated critical documents for the operation.
- Oversee the process of Change Control chain ensuring documents get routed, reviewed and approved within stipulated time frame.
- Participate in internal departmental audits as well as outside vendor audits.
- Conducted training for new employees as they get hire, and prepare and execute Annual GMP review across the entire company.
- Reviewed and approved equipment PQs.
- Supervised quality control processes to ensure compliance with industry standards.
- Developed and implemented training programs for new team members on quality assurance protocols.
- Conducted regular inspections and audits to identify areas for process improvement.
- Collaborated with cross-functional teams to resolve quality-related issues effectively.
- Analyzed test results and provided feedback for continuous improvement initiatives.
- Led root cause analysis investigations to address non-conformance events efficiently.
- Established quality metrics and monitoring systems to enhance operational performance.
- Mentored staff in best practices for maintaining product integrity and safety standards.
- Adapted procedures to mitigate issues and improve deficiencies.
- Revised and drafted policies and procedures to address deficiencies comprehensively.
- Advised and led process improvement team with deliberation, leadership and strategic planning.
- Documented nonconforming material and reported to appropriate team leaders for review and assessment.
- Maintained service records, coordinated repairs and oversaw preventive maintenance of manufacturing equipment.
- Established rigorous safety measures for high-stakes and potentially dangerous factory environments.
- Performed testing to assess product effectiveness, alignment with designed purpose and adaptations for other purposes.
- Prepared reports to dispense information for product teams and compile information supporting long-term company development and success.
- Remained compliant with federal, state and municipal regulations related to safety of company and personnel.
- Created a positive work environment that encouraged open communication among team members, fostering trust and collaboration towards achieving shared goals.
- Enhanced product quality by implementing strict inspection procedures and providing regular feedback to production teams.
- Reduced customer complaints by identifying and resolving issues in the manufacturing process quickly and efficiently.
- Increased efficiency of the Quality Control team by developing and implementing comprehensive training programs.
- Organized weekly meetings with staff members to discuss ongoing projects and troubleshoot any challenges faced during quality inspections.
Senior QA/QC Officer
Ranbaxy laboratories Limited
01.2008 - 04.2016
- Testing of raw materials, packaging material, in-process finished and stability sample by HPLC, HPTLC, ICP, GC Column Chromatography, FTIR, UV/Vis spectrophotometer, Auto titrator, Polarimetry and other analytical instruments as per GLP, GMP, FDA, Health Canada, ICH guidelines.
- Reviewed and approved equipment PQs and performed audits on clinical study reconciliations.
- Executed incident/deviation reporting/review and approval via Trackwise.
- Audit of QC data package for accuracy.
- Imparting training to staff as per requirements.
- New method development and their validation.
- Preparation of Standard Operating Procedures, Test Protocols, Validation Protocols, and reports.
- Trouble shooting, Calibration and record of maintenance of laboratory analytical instruments.
- Calibration, Validation and Qualification (IQ, OQ, PQ) of laboratory analytical instruments such as IR, UV, Analytical Balances, HPLC, GC, HPTLC, Polarimeter, , ICP.
- OOS and OOT investigations, CAPA and their implementation for process improvement.
- Maintaining compliance as per 21 CFR part 11 with analytical Computer System Validation.
- Handling regulatory audits.
Education
Master of Science - Pharmaceutical Chemistry
Bachelor of Science - Chemistry
Skills
- Qualification of Instruments
- Regulatory Compliance
- GAMP Systems Expertise
- Quality Systems
- Compliance with GMPs
- Quality Control
- Staff Training
- CAPA
- Deviations
- Chromatography techniques
- Analytical chemistry
- Spectroscopy techniques
- Equipment calibration
- Statistical software
- Gas chromatography
- Physical chemistry
- Stability sampling
- Method validation
- Laboratory safety
- Mass spectrometry
- Assay testing
- Dissolution testing
- Time management
- Problem-solving abilities
- Critical thinking
- Effective communication
- Decision-making
- Relationship building
- Team building
- Safety protocols
- Instrumental analysis
- Calibration skills
- Analytical thinking
Accomplishments
- Coordinated the successful completion of 6 major audits – USFDA, Health Canada – with zero critical observations.
- Work as SME at universal analytical laboratory and lead the Audit to Obtain Health Canada DEL.
- Validated Computerized system associated with Instrument as per GAMP guidelines.
- Validated high budgetary Software such as Empower, LIMS.
Timeline
Senior Chemist
Unilab Analytical Services Inc.
04.2024 - Current
Quality Control Manager
Universal Analytical Lab Inc.
07.2021 - 03.2024
Quality Control team lead
Canadian Analytical Laboratories Inc.
05.2016 - 07.2021
Senior QA/QC Officer
Ranbaxy laboratories Limited
01.2008 - 04.2016