RAJWANT KAUR
Brampton,Canada
Summary
To maximize my professional talent and develop my inner potential and contribute towards building a career which enables me to apply my knowledge in pharmaceutical and /or food industries.
Overview
14
14
years of professional experience
1
1
Certification
Work History
Investigator Deviation and Quality Compliance
SGS Canada
01.2022 - Current
- Conducting review and approval of risk and impact assessment analysis.
- Identifying and providing appropriate root of analysis by interviewing the personnel and documenting investigative findings.
- Support appropriate trend analysis as an outcome of the establishment compliance programs and identifying appropriate CAPAs for continuous improvement.
- Assures that OOS and deviations are closed before forwarding the records to QA for release of Certificate of Analysis
- Assures an audit form noting deficiencies to method and procedures, making corrections as per data review SOP, ensures that all valid deficiencies are corrected; escalated all concerns to management.
- Ensures that documents review is complete in every aspect and all results entered in LIMS.
- Execute CAPAs associated with Health Canada, Internal Audit, and self-inspection observation.
- Perform and review investigations (deviations, CAPAs, OOS etc.) for adequate closure, dispositions, and follow-ups.
- Review protocols, SOPs, Validation, Method development and Verification Data records
- Coordinates with Customer to address quality concerns, ensure quality standards met, and issues resolved promptly and effectively.
- Support and participate in internal and external audits (FDA and Health Canada) including client Audit.
Analytical Operations Scientist (R & D)
Thermofisher Scientific
01.2019 - 01.2022
- Test in-process, commercial and stability samples while meeting strict deadlines and following an assigned schedule.
- Performing instrumental and wet chemistry for quantitative and qualitative Analysis of API’s and excipients
- Operate and troubleshoot UV, HPLC, IR, FTIR, refractometer, viscometer, and Karl Fisher instruments to acquire data.
- Performed System Suitability as per client method requirements and assessed data before running samples.
- Perform variety of testing such as assay, related substances, physical properties, limit test and identification tests
- Follow up on major and minor deviation investigation and writing related non-conformance reports and providing corrective actions.
- Performed advanced troubleshooting of Empower to overcome system suitability failures.
- Performed TOC and HPLC analysis for Cleaning Validation and created Certificate of Analysis
- Worked in accordance with approved methods, SOPs and cGMPs while performing tests.
- Participate in internal, customer and regulatory audits.
- Worked diligently to promote department initiatives of Right First Time and On Time Delivery.
- Performed inspection of Controlled substances
- Performed cleaning validation and verification testing.
- Creating and updating templates/logbooks for Quality team to perform testing.
Quality Assurance Specialist
Johnvinve Foods/Planters Canada
01.2016 - 01.2019
- Participated and assisted HACCP Coordinator in Developing and Documenting Standard Operating Procedures, Specification, Quality Control, and processing procedures.
- Calibration of various laboratory Equipment’s such as Agtron Colorimeter, Checkpoint Analyses, Conductivity ensuring instruments are kept serviceable, troubleshooting of collected data.
- Conducted sensory Evaluation and shelf-life studies.
- Moisture Determination in process and final product.
- Performing finished product evaluation for in house products
- Updating Logbooks and reviewing Lab data
- Actively participating in meetings related to customer care investigations and resolutions.
- Performing various Analytical Testing such as Aflatoxin testing, Free Fatty acid titration
- Follow up on major and minor food safety issues and writing related non-conformance reports
- Actively dealing with Canadian food inspection agency (CFIA)
- Participated in Plant Traceability and mock recalls
Quality Assurance Technologist
Tasty Selections
01.2015 - 07.2016
- Performed pre-operational inspections and micro testing, ATP, Protein swabs to ensure sanitation level and product safety
- Conducted micro swabbing of equipment’s following company zoning process
- Participated in continuous improvements projects such as Product development
- Reviewed BRC fundamentals, HACCP plans, consumer complaints, OPL, flour tailing, glass and plastic audits
Quality Control/Quality Assurance
Panacea Biotech
05.2011 - 10.2011
- Performed analysis of laboratory samples including raw material, in-process, finished products, purified water, cleaning validation and stability samples using analytical instruments.
- Inspected and tested finished products and in coming raw materials by using UV-VIS, organic testing and disintegration testing.
- Prepared and updated SOP's, report procedures for daily activity documentation, Procedural steps and Corrective and Preventive Actions (CAPA)
- Compiled and analyzed all observations and data obtained from testing as per established SOPs and good documentation practices.
- Performed Lab testing using HPLC, GC, UV-VIS, SDS-PAGE, ELISA
- Performed proper bench work including Centrifuge, ultra-filtration and SDS-PAGE, water content using Karl Fisher, Viscosity and Standardization by Titration.
Education
Regulatory Affairs and Quality Compliance -
Seneca-North York
North York, ON04-2025
Project Management Professionals (Certification) - undefined
Project Management Institute
01.2024
Biotechnology Technologist - Industrial Microbiology
Scarborough
Scarborough, ON01.2014
Bachelor of Pharmacy - Pharmaceutical Sciences
Amritsar
Amritsar, Punjab01.2012
Skills
- Sample Handling (Retaining & Reconciliation)
- COA Release
- NHP,NDS,CTA
- Method Development
- Drug development
- Software (SAP, track wise, DocuSign)
- CAPA, RCA
- Knowledge of ISO 9001 & 13485
- Positive attitude and self-motivation
- Detailed report writing
- Interview techniques
- Risk assessment
Training
- Certification internal auditing by SGS 2018
- Environmental Monitoring by SGS 2018
- Project Management Professional 2024
Languages
English
Certification
Project Management professionals(PMP) and
Regulatory affairs and quality compliance
Timeline
Investigator Deviation and Quality Compliance
SGS Canada
01.2022 - Current
Analytical Operations Scientist (R & D)
Thermofisher Scientific
01.2019 - 01.2022
Quality Assurance Specialist
Johnvinve Foods/Planters Canada
01.2016 - 01.2019
Quality Assurance Technologist
Tasty Selections
01.2015 - 07.2016
Quality Control/Quality Assurance
Panacea Biotech
05.2011 - 10.2011
Project Management Professionals (Certification) - undefined
Project Management Institute
Biotechnology Technologist - Industrial Microbiology
Scarborough
Regulatory Affairs and Quality Compliance -
Seneca-North York
Bachelor of Pharmacy - Pharmaceutical Sciences
Amritsar
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