Summary
Overview
Work History
Education
Skills
Certification
Educational Background
References
Timeline
Generic

Sucheta Solanki

Edmonton,Canada

Summary

  • Result-driven Quality Management professional with over 10 years of relevant experience in manufacturing environments (including pharmaceuticals, medical devices, and cannabis products).
  • Experienced Quality Assurance Specialist with a strong background in implementing and maintaining QMS to ensure compliance with regulatory standards by Health Canada and the FDA.
  • Methodical auditing skills with efficient risk identification methods. Proactively addressed audit findings, implementing corrective and preventive actions to mitigate risks and ensure ongoing compliance.
  • Working knowledge of a fast-paced GMP-compliant environment and has a track record of success in managing quality systems.
  • Proven track record of driving continuous improvement initiatives and leading successful quality management teams.
  • Sound understanding of the Blood regulation and Part C of Food and Drug Regulation defined by Health Canada, CSA Blood and Blood Component Standards (CAN/CSA-Z90:20 sterilization requirements)
  • Enhanced comprehension of International standards (ISO 13485:9001 and ISO/IEC 17025) in adopting sustainable and ethical practices for providing high quality product and services
  • Experience in NCR & Deviation Investigation, Root Cause Analysis, CAPA Closure, Change Control, Validation, Document Management, Technical Writing, Product Complaints, SOP Review, and Development in a GMP-Compliant Environments.
  • Proficient in Microsoft office (Outlook, Word, and PowerPoint), Quality management software, and ERP-based systems
  • Productive multitasker with strong interpersonal and problem-solving skills.
  • Master's of Science in Biochemistry foundation with a dynamic role in leading projects using innovative stem-cell therapy in the treatment of type-1 diabetes patients.
  • Currently working towards the Regulatory affairs and Quality Assurance certifications course from Seneca College, North York, ON, with a tentative completion date of Oct 2024.
  • CAPRA member (Canadian association of professionals in regulatory affairs) since Aug 2021.

Overview

10
10
years of professional experience
1
1
Certification

Work History

Quality Assurance Specialist

Gilead Sciences, Alberta (ULC)
Edmonton, Canada
04.2023 - Current
  • Led cross-functional teams to identify root causes of quality issues and implement corrective and preventive actions, resulting in improved product safety, efficacy and quality of pharmaceutical products
  • Participate in the development of training programmes through electronic documentation and training systems (e.g., Gvault and GxPlearn) ensuring company-wide GMP compliance and understanding.
  • Perform QA inspections of final API and review associated documentation prior to shipping material offsite
  • Involved in internal quality audits and routine inspections of production and warehouse areas in timely manner and assist QA management in Audit compliance
  • Act as a liaison between other Quality departments to ensure materials management follow GMP and Company’s internal requirements
  • Act as a lead of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products
  • Managed evaluations of GMP materials and services by analyzing its data and facilitating Root cause analysis for non-conforming materials by the applicable eQMS
  • Using an eight-step approach for root cause analysis in deviations to find underlying issues that lead to discrepancies, thereby improving product quality, ensuring regulatory compliance, and enhancing overall operational efficiency
  • Coordinate activities associated with disposition of material status using material management system (EBS)
  • Review structured change controls associated with validation process while complying with regulatory requirements
  • Review Batch production records and analytical test records. Communicate to QA, QC and Operations the status of batch record reviews and any documentation required for compliance with procedures and test methods
  • Revise documents which include but are not limited to the following: Standard operating procedures, work instructions, specifications, and forms
  • Create/Revise Quality and Regulatory documents (gap assessments for Quality Agreements with contract manufacturers, risk assessments, reports, Drug Establishments renewal) using document management systems.

Quality Control Associate

Hello fresh, Edmonton
Edmonton, Canada
01.2023 - 03.2023
  • Conduct quality control inspections to ensure products adhere to required specifications for the received inbounding and inventory SKUs
  • Lead production associates for ingredient sorting by performing quality control inspections on work-in-progress and finished products to ensure products meet Canadians Food Safety Regulations and GFSI schemes
  • Work in compliance with OH&S acts and regulations
  • Perform regular inspections on packaged products for lot codes by working closely with the Warehouse team to achieve quality targets
  • Communicate with cross-functional teams in cases of product non-conformance, maintaining a photo database of product non-conformances.

Quality Assurance Associate

PBG Biopharma, Inc
Edmonton, Canada
05.2022 - 07.2022
  • Develop and maintain the company’s quality system in compliance with the regulatory standards for Health Canada, ISO/IEC 17025
  • Developed, revised, and updated SOP’s and control forms related to NHP and Cannabis/hemp products
  • Perform QA checks such as GMP, Pre-operational inspections, Environmental monitoring to ensure the conformity of finished products throughout the manufacturing process
  • Reviews production batch records, testing results and related documents for product release
  • Involved in initiating and approving change controls while performing required corrective actions
  • Educate and assist with training the employees for improved compliance with quality system adhering to the regulatory standards
  • Managed employee training and records electronically and with paper-based copies
  • Involved in preparing training material as needed
  • Working knowledge of analytical instruments (e.g., HPLC, LCMS) and its software for routine sample login, testing, and its analysis
  • Participated in subject group meetings and training sessions on regular basis
  • Underwent training held by Agilent for operation of LIMS software for managing lab samples & test results.

Quality Assurance Auditor

Aurora Cannabis, Inc
Edmonton, Canada
07.2021 - 04.2022
  • Provided guidance to manufacturing with respect to GMP, GDP, GPP
  • Performed quality oversight and line clearance support on cleanroom floor for manufacturing operations of Medical Cannabis and Edible products
  • Perform GMP audits, pre-operational inspections, sanitation verifications and allergen testing
  • Conduct routine Sterility checks to ensure equipment and rooms meet specifications
  • Conduct glass and brittle plastics inspections and lighting checks
  • Review analytical data (COA) obtained from certified labs by ensuring product compliance and specifications
  • Assisting with conducting risk assessments and investigations regarding deviations or product complaints, including gathering of data, identification of root causes, and performing mitigation steps on product’s quality and safety for its intended use
  • Conduct inspection of initial raw materials and final finished product to verify that the product meets quality specifications
  • Perform internal auditing of records, including sanitation, logbooks for clean rooms, and manufacturing equipment's
  • Perform Work Order verification of e-beamed sterilized cannabis products and controlled material release using SageX3-ERP software
  • Audit packaging/labelling sites to monitor and assure adherence to cannabis quality system requirements
  • Perform production batch records/logbooks review and verify that documentation is completed as per GDP
  • Profound understanding of QMS software’s tools and processes to identify quality issues and take corrective actions.

Research Assistant

University of Alberta
Edmonton, Canada
07.2019 - 07.2021
  • Lead research projects while elucidating the role of anti-diabetic drugs in diabetic induced mice models
  • Performed stem cell culture using aseptic techniques and GLP for procedures like cell isolation, transplantation, tissue collection and serum/plasma processing for biological markers
  • Routine Molecular biology techniques like DNA extraction, PCR, gel electrophoresis, cloning, cell culture maintenance and differentiation
  • Able to independently perform experiments, execute data end-point collections, and analyse and interpret scientific data using different statistical tools in the graph-pad prism like t-tests, ANOVA, linear and non-linear regression analysis, and survival graphs
  • Involved in various scientific instrument & equipment maintenance and calibration
  • Conducted diligent verification for errors and troubleshooting in data collection, analysis, and interpretation
  • Experienced working with biosafety level 2 environment following GLP, GDP, equipment maintenance and calibration, laboratory reagent preparation, testing, and analysis.

Quality Control Lab Technician

Nanospeed Diagnostic, Inc.
Edmonton, Canada
01.2014 - 05.2019
  • Led the design, development, and validation of an innovative immunodiagnostic product at Nanospeed Diagnostics, resulting in its successful commercialization.
  • Managed the validation process, ensuring compliance with regulatory requirements and delivering a high-quality product that met customer needs.
  • Routine QC testing to define product specification and optimized assay performance for out-going diagnostic kits
  • Executed calibration, maintenance, and validation of laboratory instruments
  • Perform routine clinical specimen testing, data analysis and reporting
  • Recorded and interpreted laboratory results to present to senior colleagues
  • Monitor manufacturing and other processing parameters and take corrective actions as directed by Supervisor
  • Good understanding of safety and decontamination methods using human specimens (like blood, plasma, and serum).

Education

Quality Assurance Specialist -

Gilead Sciences
Edmonton, AB
04-2023

Quality Control Associate -

Hello Fresh
Edmonton, AB
01-2023

Quality Assurance Associate -

PBG Biopharma
Edmonton, AB
05-2022

Quality Assurance Auditor

Aurora Cannabis
Edmonton, AB
07-2021

Research Assistant

University of Alberta
Edmonton, AB
07-2019

Lab Tech (Quality Control/Assay Development)

Nanospeed Diagnostics, Inc
Edmonton, AB
01-2014

Image Application Analyst

Carl Zeiss Microscopy
India
12-2011

Quality Assurance Chemist

Reckon Diagnostics, Inc
India
10-2009

Skills

  • Quality Management Systems (QMS) Implementation
  • Root Cause Analysis and Corrective Action Implementation
  • Document Review
  • Quality Control Analysis
  • Statistical analyses
  • Internal Quality Audits
  • Site Inspection Readiness
  • Regulatory Compliance (Health Canada, FDA, ICH and GMP principles and standards)
  • Analytical Problem-solving
  • System Thinking

Certification

  • WHMIS-2019: University of Alberta & Gilead Sciences
  • Biosafety training for GLP, University of Alberta
  • Laboratory and Chemical Safety, University of Alberta
  • Animal Handling and procedure, University of Alberta
  • Internal Corporate training on Good manufacturing practices, Good Documentation Practices, Quality Management Systems (Master Control, Veeva Vault) and ERP systems (SAGE-X3, EBS)
  • Risk and Quality Management (QRM) Application (1-Day), Gilead, Alberta, February 8, 2024
  • Additional training and workshops related to GMP, GLP, GCP, QA/QC, and scientific report writing from BioTalent Canada in the field of regenerative medicine (stem cell network) in 2021.

Educational Background

  • Regulatory Affairs and Quality Operation Certification (RAQC) from October 2022 (Seneca College, ON)
  • Master's of Science (Major-Biochemistry) in 2009 (M.S University, India)
  • Master's of Science (Zoology, Chemistry, Botany) in 2007 (M.S. University, India)

References

Provided upon request

Timeline

Quality Assurance Specialist

Gilead Sciences, Alberta (ULC)
04.2023 - Current

Quality Control Associate

Hello fresh, Edmonton
01.2023 - 03.2023

Quality Assurance Associate

PBG Biopharma, Inc
05.2022 - 07.2022

Quality Assurance Auditor

Aurora Cannabis, Inc
07.2021 - 04.2022

Research Assistant

University of Alberta
07.2019 - 07.2021

Quality Control Lab Technician

Nanospeed Diagnostic, Inc.
01.2014 - 05.2019

Quality Assurance Specialist -

Gilead Sciences

Quality Control Associate -

Hello Fresh

Quality Assurance Associate -

PBG Biopharma

Quality Assurance Auditor

Aurora Cannabis

Research Assistant

University of Alberta

Lab Tech (Quality Control/Assay Development)

Nanospeed Diagnostics, Inc

Image Application Analyst

Carl Zeiss Microscopy

Quality Assurance Chemist

Reckon Diagnostics, Inc

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