Palak Patel
Summary
Meticulous chemist with working experience in pharmaceuticals, cannabis, and their quality department. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
4
4
years of professional experience
Work History
QC Analytical laboratory Technician
Aurora Cannabis Enterprises Inc
01.2023 - Current
- Carried out the method development for known and unknown impurities in the product by HPLC, UPLC, and RRLC by changing the selectivity using gradient optimization tactics, stationary phase, and mobile phase selection
- Communicating with the service engineer and technologist regarding resource management and troubleshooting of instruments
- Reviewed, complied, and interpreted HPLC, moisture analyzer, UPLC and RRLC analytical data and ensure on-time dispatch to Product and development department.
- Prepare standards and samples by using scientific pipettes and other laboratory apparatus
- Troubleshoot analytical instruments for system pressure (high, low, erratic), abnormal peak shape, changes in peak retention time, poor detector response, leakage detection, flow cell cleaning and spotting blockage in the system
- Follow industry standards in maintaining chromatography instruments, columns, and accessories
- Held brainstorming sessions with teammates to discuss workflow and scientific solution
- Trained and observed the growth of subordinates and co-op students and provide them with an annual progress plan and necessary training
- Work with corporate quality to develop the project charter and execution plan for the continuance process development of the department
- Dispose of samples in accordance with Health Canada guidelines and health and safety regulations
- Participate in Deviation Investigation Report (DIR), finding Root cause and provide proper Root Cause Analysis (RCA)
- Review the documents and data related to but not limited to the Quality and lab department
- Perform sampling for the third-party lab and review the results according to cannabis specification for potency, heavy metal, and pesticides and related tests
Pharmaceutical GU/CU Encapsulation Operator
Catalent pharma solution
08.2022 - 01.2023
- Perform calculation of required raw materials such as glycerin, purified water, sorbitol, and gelatin for batch as per MBPR
- Execute all required steps for producing soft gel for medicine
- Examine viscosity of soft gel, calculate required dyes for generate color for soft gel
- Handle equipment such as Gel Melter, viscometer, ross mixer, and ystral
- Maintained all day-to-day register, checklist, and clean tags of all equipment and instrument
- Worked in accordance with approved methods, SOPs, safety guidelines and cGMP while performing the duties.
Quality Control Chemist
Torrent Pharmaceuticals Ltd
08.2020 - 10.2021
- Performed Assay, CU, RS, and Dissolution test of sample on HPLC (Waters, Shimadzu, and RRLC) as per in house, USP or EP or by following lab protocols and STPs
- Interpreted and evaluated data, spectra, and chromatograms on software (Empower-3) in terms of accuracy and precision in compliance with internal SOPs and STPs and reported on Deviation from specified requirements
- Performed Analysis of Laboratory samples including in-process, semi-finished/finished products and cleaning validation using established analytical procedure and techniques
- Hands on experience on analytical instruments such as HPLC, PH-Meter, Balance, UPLC and KF
- In depth theoretical knowledge of analytical instruments such as GC, IR, UV, and Dissolution
- Recognized OOS and OOT results as per COA and, promptly reported them to the QC Lab Supervisor and helped in the completion of laboratories investigation
- Maintained all day-to-day register, checklist, logs and e-log books of all areas, instruments, and equipment
- Worked in accordance with approved methods, SOPs and cGMPs/GLPs while performing the test
- Responsible for the training of others on routine analysis, safety, compliance, troubleshooting, and all laboratory process
- Reviewed, Authorized and Released Other analyst completed data packets to the quality assurance group.
Education
Master of Science - Organic Chemistry
Kadi Sarva Vishwavidyalaya University
Gandhinagar, India01.2020
Bachelor of Science - Chemistry
Gujarat University
Ahmedabad, India01.2018
Skills
- Chromatography
- Regulatory Compliance
- Method Development
- Chemistry expertise
- Audit facing USFDA, MHRA, Health Canada
- Follow GMP, GLP, GDP
- Microsoft office (Word, Excel, PowerPoint)
- Knowledge of Stability ICH guidelines
- Quality Control Analysis
- Data Interpretation
- Sample Preparation
- Analytical Thinking
- Excellent Communication
- Interpersonal Skills
- Professional Demeanor
Languages
English
Native or Bilingual
Hindi
Native or Bilingual
References
Detailed Professional References Available upon request.
Timeline
QC Analytical laboratory Technician
Aurora Cannabis Enterprises Inc
01.2023 - Current
Pharmaceutical GU/CU Encapsulation Operator
Catalent pharma solution
08.2022 - 01.2023
Quality Control Chemist
Torrent Pharmaceuticals Ltd
08.2020 - 10.2021
Master of Science - Organic Chemistry
Kadi Sarva Vishwavidyalaya University
Bachelor of Science - Chemistry
Gujarat University
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