Open To Work
MEGHA DESAI
Whitby,Canada
Summary
Quality Control Analyst with a broad-based background. More than 6+ years of experience in the field of Quality department for the pharmaceutical industry. Manage analytical testing and Investigation out of specification results (OOS). Review testing data and other GMP documents to ensure compliance with Standard Operating Procedures, cGMP, and Quality requirements outlined by Regulatory Authorities.
Overview
12
12
years of professional experience
1
1
Certification
Work History
R&D Chemist Formulation Support/Stability
Biolab pharmaceuticals
Mississauga, Ontario
08.2024 - Current
- Assist in the development and validation of analytical test method.
- Working with writing a method validation report and method development report.
- Perform chemical and physical analysis for formulation trials, optimization batches, process validation batches and stability batches.
- Proficient in operating routine laboratory equipment such as HPLC, Dissolution, GC, UV, Karl Fischer.
- Utilized Empower and Chromeleon software for data acquisition, processing, and reporting while ensuring ALCOA+ data integrity principles.
- Developed and Validated HPLC analytical methods for Assay and related compounds (RC) for Solid dosage forms in compliance with ANVISA and USP guidelines under the supervision of Scientist.
- Performed dissolution method development and optimization, including media selection apparatus choice, rotation speed and sampling time points.
- Executed forced degradation studies to establish stability-indicating methods for assay and impurity.
- Assisted in and independently performed analytical method validation (accuracy, precision, linearity, Specificity, robustness as per ICH.
- Supported method transfer activities.
- Initiated and supported Change Controlled request (CCR) related to analytical method development, validation and optimization.
- Conducted experiments to develop new pharmaceutical formulations.
National Business Sales Advisor
Shaw Communications
Winnipeg, Canada
06.2022 - 07.2023
- Maintaining an in-depth knowledge of store products to provide suitable recommendations to customers as per their requirement.
- Addressing customers concerns and inquiries as well as resolving any complaints.
- Answering telephone calls in a courteous and professional manner.
- Continuously updating the knowledge of the company products, services and policies.
- Facilitate sales transaction by advising customers on suitable products that best meet their needs and encourage purchase and process customer payment.
- Handling all discounts, price change and promotional offers.
- Providing information and other services such as information of internet and other technical services.
- Approaching customers and offering them advice on products to persuade them to buy.
- Greeting customers, responding to questions, improving the knowledge outstanding customer service.
- Achieving established goals and increasing company sales.
- Cross selling product to increase purchase amount.
Quality Control Analyst
Vita Health Product Inc, NBTY
Winnipeg, Canada
08.2018 - 06.2022
- Proficient while using numerous laboratory instruments, High-performance liquid chromatography (HPLC), UPLC, and spectroscopy techniques like IR and UV, titration, Moisture test (KarlFisher), TLC, GC, Dissolution Tester, Disintegrator and other instruments.
- Prepare reagents, standard, and sample solutions. Analyze inorganic and organic compounds according to pre-defined test methods and relevant pharmacopeia like USP, EP.
- Ensure analytical records are accurate, clearly laid out, legible, and recorded at the time of the task.
- Interpret data using specialized software (Empower and LIMS) and reporting scientific results.
- Involve in the Laboratory Investigation (OOS Results) to determine possible causes of the out-of specification results.
- Participate in method transfers and new product introduction exercises.
- Provide feedback to Team Manager and other staff.
- Face Health Canada Audit and regular in-house audits.
- Involve in Gap identification and improvement of Standard Operation Procedure and other Quality Control Documents.
- Responsible for providing training & guidance to junior staff.
- Maintain a safe and healthy work environment, follow all safety policies (WHMIS), and report any potentially unsafe conditions within the workplace.
- Supports continuous improvement activities within the Laboratory, regulatory identifying areas for improvement in compliance, 5S standards, safety or efficiency, and participates in the implementation of changes.
- Maintain laboratory equipment according to SOPs, standard work guidelines, and calibrating laboratory instruments like Balance, PH meter.
- Following ALCOA, GMP, GLP, and SOP to maintain correct quality standards within Laboratory.
- Good Knowledge of Microsoft Office.
Quality Control Technician
HQ Fine Food
Edmonton, Canada
03.2018 - 07.2018
- Followed and complied with good manufacturing practices, safety, and quality assurance practices.
- Monitored cleaning records.
- Perform pre-operational check, sanitation verification, and label verification.
- Perform equipment calibration check.
- Troubleshoot quality and production issues and made recommendations to management.
- Verified and maintained in-house and third-party laboratory testing results.
- Ensured GMP procedures and HACCP followed.
- Involve in the swab testing for sanitation checks.
- Maintain the product specification sheet for finished products.
Quality Control Analyst/Chemist
Ami Life Science Pvt. Ltd
Gujarat, India
07.2014 - 11.2016
- Analyzed samples according to pre-defined test methods, specifications, or pharmacopeia.
- Perform analysis using laboratory instruments, including High-performance liquid chromatography (HPLC), spectroscopy techniques like IR and UV, titration, Moisture test (Karl-Fisher), TLC, Dissolution Tester, Disintegrator, and other Analytical instruments.
- Prepared reagents, standard, control, and sample solutions.
- Performed analytical testing for solid dosage, and liquid dosage (injection, suspension) forms.
- Following GMP, GLP, and SOP to maintain correct quality standards within Laboratory.
- Performed daily calibration for laboratory instruments like balance, pH meter.
- Elysium Pharmaceuticals
Education
Master of Organic Chemistry -
Sardar Patel University
Vallabh Vidyanagar, India 03.2012 - 01/2014
Bachelor of Chemistry Science -
Vallabh Vidyanagar, IndiaSkills
- Problem-solving
- Troubleshooting analytical equipment
- Statistical and mathematical tools
- Team collaboration
- Sharing feedback
- Working under pressure
- Teamwork
- Organizational skills
- Analytical skills
- Time management
- Multidisciplinary teamwork
- High-intensity environments
- Communication skills
Certification
Canadian Equivalency of Master Degree, WES reference No:.3601022
Timeline
R&D Chemist Formulation Support/Stability
Biolab pharmaceuticals
08.2024 - Current
National Business Sales Advisor
Shaw Communications
06.2022 - 07.2023
Quality Control Analyst
Vita Health Product Inc, NBTY
08.2018 - 06.2022
Quality Control Technician
HQ Fine Food
03.2018 - 07.2018
Quality Control Analyst/Chemist
Ami Life Science Pvt. Ltd
07.2014 - 11.2016
Master of Organic Chemistry -
Sardar Patel University
03.2012 - 01/2014