Antara Paul
Brossard,QC
Summary
Hard-working and highly motivated Quality Assurance Specialist with more than 2 years of experience in GMP industry (pharmaceutical) and more than 9 years of experience in GLP industry (Microbiology laboratory). Proven track record of consistently meeting and exceeding quality standards while maintaining high levels of accuracy and attention to detail. Determined and dedicated worker of the project team with problem solving attitude and ability to quickly learn new technologies.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist-Level 1
Medisca INC-Saint Laurent
03.2024 - Current
- Create product Certificate of Analysis (CoA), product specification according to effective pharmacopoeia and creating product labels for all API and Non-API chemicals and certificate of conformity for all applicable devices.
- Creating and maintaining quality documents for customer notifications and allergen statements.
- Review and Approve Certificates of Analysis (CoA) and Certificates of Conformance (CoC) to ensure compliance with quality and regulatory standards.
- Assist in preparation and execution of regulatory inspections, ensuring all required documents are readily available.
- Assist in investigation of quality issues related to product complaints and root cause analysis.
- Participate in annual cross-functional projects to support organizational goals and continuous improvement initiatives.
- Good knowledge of GMP, USP and Health Canada Guidelines.
- Good knowledge of working with QMS applications, Master Control, Syspro etc.
Quality Control Inspector
Medisca INC-Saint Laurent
03.2023 - 03.2024
- Review receiving documents and perform thorough inspection of finished products, APIs, bulk materials, medical devices, Packaging components in accordance with GMP protocols and company's quality standards.
- Ensure that all external and internal requirements are met, before releasing API products to sellable inventory.
- Monitor and retrieve temperature data from data loggers received with each shipment and ensure to log and check for any excursion before the release process.
- Collaborate with the cross-functional teams to address quality issues, deviations and implement corrective actions in alignment with GMP principles.
- Perform daily pre-production audits, post-production audits, WIP release for re-packaging and re-labelling materials in the production site.
- Determine various testing requirements for non-API bulk Materials, Chemicals, Reagents, Packaging components that require testing, following specifications, USP/EP requirements, or manufacturer requirements.
- Issue Purchase orders, sample analysis request forms for external labs and communicate effectively with the labs.
- Document detailed record of inspection, test results or any non-conformances identified to ensure documentation meets GMP documentation standards.
- Document and handle retain samples, rejected expired materials at the end of each month.
- Assist the QC supervisor and Quality Manager in internal audits and external audits.
- Trained and mentored junior inspection staff and interns to apply best practices and comply with quality control guidelines and regulations.
- Streamlined the inspection process, resulting in quicker identification of defects and faster corrective actions.
Quality Control Microbiologist
Pathogenca Inc
10.2022 - 03.2023
- Performed the sampling and microbial Examination Test of food, medical cannabis, water, environmental samples in a timely fashion.
- Knowledge of Aseptic technique, GLPs, GMPs
- Executed microbiology methods and validation protocols.
- Ensured all the work is performed in compliance with GMP procedures.
- Recorded data, analyzed test results, and kept meticulous reports using LIMS software.
- Maintained and qualified microbial stock cultures.
- Performed environmental monitoring air, surface monitoring of rooms and water systems (purified and potable) microbial monitoring.
- Participated in the Laboratory Investigations, Out of Specification Investigations, Change Control and CAPA programs.
Research Fellow
Assam Agricultural University
11.2013 - 03.2022
- Isolated, screened and characterized native biofertilizer organisms from rhizosphere soil sample.
- Conducted various tests, analyzed the results, prepared reports based on the findings to culture and identify efficient biofertilizer organisms.
- Conducted field experimentation incorporating various treatments, collected data and prepared final reports.
- Handled various Laboratory Equipment such as, UV-VIS Spectrophotometer, Electronic Balance, Leica Compound Microscope, B.O.D incubator, Environmental Shaker, Gel Electrophoresis Unit, Gel Documentation Unit, PCR, Ultra Centrifuge, Gas liquid Chromatograph etc.
- Maintained logbook, purchase orders of equipment, chemicals, and glassware etc.
- Prepared presentation, bulletins, compendiums, papers etc.
- Imparted hands-on training and demonstration to the local farmers, NGO's, Entrepreneurs, and young students.
Education
Master of Science - Microbiology
Annamalai University
05.2013
Bachelor of Science - Zoology
Dibrugarh University
07.2011
Higher Secondary - Science
Pinewood Junior College
05.2008
Skills
- Quality Assurance
- Quality Control
- Release and inspection
- Sampling Protocols
- GMP procedures
- Writing and Presentation
- Record-Keeping
- Microsoft Office Applications (MS Word, MS Excel, MS PowerPoint, Outlook)
- Internet, Emails
- Google Workspace, Docs, Sheets, Meet, Calendar etc
- Data Entry in Excel
- Detail-oriented
Languages
English - Professional
French - A1 Beginner
Certification
- Successfully completed the online course “Food Safety and food Microbiology” conducted by SWAYAM Portal and offered by Central University of Haryana, India with a score of 80% - 2022
- Successfully completed an online certificate course “ Good Manufacturing Practices Certification Course” in Udemy online learning platform- 2024
Hobbies and Interests
Music, Travel
Training
- Participated in National Seminar on “Golden Thoughts on Current Microbial Research”
- Participated in a conference on “Preserving Future Genetic resources through capacity building of women farmers and utilization for livelihood Improvement”, organized by DBT India.
- Successfully completed two days workshop on “Use of Bio-Inputs for Growing Organic tea” organized by DBT-AAU Centre
Disclaimer
I, Antara Paul hereby, declare that the information furnished above are true to the best of my knowledge.
PERSONAL STRENGTH
- Quick at Learning
- Patient by nature
- Good Communication Skills.
- Leadership quality.
- Adaptable and Efficient.
- Can work effectively in a team, as well as individually.
- Self-motivating and Hard working
- Ability to deal with a person diplomatically.
Timeline
Quality Assurance Specialist-Level 1
Medisca INC-Saint Laurent
03.2024 - Current
Quality Control Inspector
Medisca INC-Saint Laurent
03.2023 - 03.2024
Quality Control Microbiologist
Pathogenca Inc
10.2022 - 03.2023
Research Fellow
Assam Agricultural University
11.2013 - 03.2022
Higher Secondary - Science
Pinewood Junior College
Master of Science - Microbiology
Annamalai University
Bachelor of Science - Zoology
Dibrugarh University
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