Jatinder Kapoor
Brampton,ON
Summary
- Pharmaceutical industry professional with high calibre 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.
Overview
15
15
years of professional experience
Work History
Quality Assurance Specialist
Universal Analytical Laboratories Inc.
Brampton, ON
07.2021 - Current
- Responsible for implementing and enforcing the compliance of the quality systems in place.
- Creating, editing, reviewing, approving and distributing of standard operating procedure. Scheduling and executing the periodic review of standard operating procedure in the QMS.
- Work in partnerships with other departments to ensure processes are aligned with Standard Operating Procedures (SOPs) and Good Manufacturing Practices (cGMPs), as well as other state and federal agencies.
- Maintained a close schedule of internal and external audits as required.
- Maintain a system of Deviations/Investigations and CAPAs related to to the processes carry out in house.
- Manage and monitoring the daily quality activities in the operation
- Participated in quality improvement teams to reduce defects and quality issues, and other projects required by management.
- Monitored daily quality activities of the Quality team, Supporting the quality training program for all levels of the company Identified issues affecting efficiencies and develop solutions to presented challenges Lead and monitor the internal GMP audit program Lead and monitor and support the on-time closure of assigned deviations and CAPA Reported weekly and Monthly Quality metrics to Leadership tem Kept accurate employee records; file proper reports (accident, probation, etc) Managed, and coached associates on a regular basis and as needed Supported the Quality team members to ensure products and processes comply with the relevant requirements of the quality management system Monitored the compliance of processes and associated records to company standard operating procedure requirements and work closely with operations and R&D if changes are necessary.
Quality Assurance Associate
Canadian Analytical Laboratories Inc.
Mississauga, ON
05.2016 - 07.2021
- 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.
- Generate electronic database to organize SOP documents in different categories for a better tracking of current, documents, documents with pending reviews and updates, and obsolete documents.
- Perform SOP review for all documents based on a 2 year review plan.
- Perform GAP reviews on SOPs to bring all documents to a stage of compliance of documents and processes.
- Write SOPs on different processes as required, update current documents based on actual processes and practices.
- Participates on the review process of customer complaints received and the answer to those complaints based on complaints investigation founding's.
- Participate in the generation, review and approval of planned unplanned deviations generated as required.
- Facilitate training for new employees, training to existing personnel based on new / SOP updates, as well as the Annual GMP review across the company.
Senior Quality Control Officer
Ranbaxy laboratories Limited
Mohali, Punjab
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 Quality Assurance And Quality Control
Hemvati Nandan Bahuguna Garhwal University
India07.2006
Bachelor of Science - Chemistry
Guru Nanak Dev University
India04.2002
Skills
- Internal Audits
- Regulatory Compliance
- GAMP Systems Expertise
- Quality Systems
- Compliance with GMPs
- Quality Control
- Staff Training
- CAPA
- Deviations
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
Quality Assurance Specialist
Universal Analytical Laboratories Inc.
07.2021 - Current
Quality Assurance Associate
Canadian Analytical Laboratories Inc.
05.2016 - 07.2021
Senior Quality Control Officer
Ranbaxy laboratories Limited
01.2008 - 04.2016
Master of Science - Pharmaceutical Quality Assurance And Quality Control
Hemvati Nandan Bahuguna Garhwal University
Bachelor of Science - Chemistry
Guru Nanak Dev University
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