NIKI PATEL
Calgary,Canada
Summary
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Overview
11
11
years of professional experience
Work History
Executive
Umedica Laboratories Pvt. Ltd.
09.2022 - 10.2023
- Efficiently handled Quality Management System (QMS) tools, like Out-of-specification (OOS), Incidents, Deviation, Change controls, etc as a lead investigator, leading to a 70% reduction in repetitive work and ensuring compliance documentation and meeting quality objectives
- Conducted instrument operations and troubleshooting, resulting in a 20% increase in instrument utilization
- Supervised stability section for sample schedule withdrawal, testing, and data review, reducing 80% of contract laboratory testing and ensuring a 70% improvement in workflow, providing technical support, and adhering to quality and safety standards
- Developed second-line staff for critical thinking and problem-solving abilities, resulting in a 40-50% increase in team productivity.
Executive
Exemed Pharmaceuticals
05.2020 - 08.2022
- Executed the investigations for OOS, OOT, Incidents, and Root cause analysis for deviation for the quality control laboratory and analytical data records
- Initiated and implemented CAPA, and trained analysts, achieving a 50% reduction of analytical and laboratory errors
- Performed analytical raw data analysis and instrument calibration review, resulting in an 80% reduction in measurement errors supporting audits for quality certification and compliance
- Communicated effectively with team members and other departments, contributing to a 70% increase in cross-departmental collaboration
- Managed laboratory instruments and equipment, overseeing their qualification, calibration, operation, and troubleshooting to ensure optimal functionality.
Executive
Alkem Laboratories Ltd.
04.2017 - 04.2020
- Prepared standard operating procedures and conducted training, for its effective implementation and its periodic review
- Efficiently responded to audit observation and targeted regulatory compliance
- Facilitated new lab setup along with instrument qualification and software implementation, contributing to an 80% increase in operational efficiency, ensuring computer system validation, and performing challenge study complying with 21 CFR
- Performed instrument calibration and maintained laboratory records, ensuring traceability, as a part of the Lab support team
- Conducted analysis using chromatography, spectroscopy, and chemical and physical separation techniques
- Coordinated training for scheduled and unscheduled training, ensuring effectiveness
- Management of Reference/ impurity standards and HPLC/GC columns, ensuring 100% availability before the analysis plan.
Senior officer
Umedica Laboratories Pvt. Ltd.
03.2016 - 04.2017
- Analysis of drug products, raw materials, and finished products using analytical instruments, chromatography, spectroscopy, chemical and physical techniques, and methods, with data compliance and result recording
- Working standard qualification and Reference/ impurity standards procurement and control
- Calibration of laboratory instruments in a compliant manner and recording data for traceability.
Officer
Sovereign Pharma Pvt. Ltd.
01.2013 - 02.2016
- Preparation, revision & handling of Specification, Method of Analysis, standard operating procedures, and their implementation
- Preparation of reagents, volumetric solutions, and reference materials
- Management of reagents & chemicals (inventory, control stocks, record maintenance)
- Maintaining records for lab cleaning, temperature, and humidity
- Analysis of raw material and finished product and calibration of laboratory instruments.
Education
Bachelor of Pharmacy -
Rajiv Gandhi University of Health and Sciences
08.2012
Skills
- Attention to Detail
- Flexible and Adaptable
- Dependable and Responsible
- Multitasking Abilities
- Excellent Communication
- Critical Thinking
- Problem-Solving
- Customer Service
- Teamwork and Collaboration
- Friendly, Positive Attitude
- Organization and Time Management
- Computer Skills
Country
Canada
Languages
English
Full Professional
Hindi
Full Professional
Gujarati
Native or Bilingual
Punjabi
Elementary
Marathi
Elementary
Timeline
Executive
Umedica Laboratories Pvt. Ltd.
09.2022 - 10.2023
Executive
Exemed Pharmaceuticals
05.2020 - 08.2022
Executive
Alkem Laboratories Ltd.
04.2017 - 04.2020
Senior officer
Umedica Laboratories Pvt. Ltd.
03.2016 - 04.2017
Officer
Sovereign Pharma Pvt. Ltd.
01.2013 - 02.2016
Bachelor of Pharmacy -
Rajiv Gandhi University of Health and Sciences
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