SHARON REJI
North York
Summary
Dynamic professional with extensive experience in technical coordination and project leadership, specializing in change management and process improvement. Proven expertise in equipment management, problem-solving, and fostering effective communication among teams. Committed to leveraging skills to excel as a Manager, driving team success and implementing strategic initiatives. Passionate about contributing to a collaborative and innovative environment that embraces growth and efficiency.
Overview
7
7
years of professional experience
1
1
Certification
Work History
Technical Administrator
Sanofi Pasteur Limited
05.2024 - Current
- Currently leading Site Change Controls, Project Change Controls, and CAPA implementations as needed until completion as per committed due dates in B100 Upstream.
- Coordinating with different departments for the successful closure of Work orders in SAP and assisted in B100 DIP and TET Go-Live.
- Currently leading daily afternoon LO +QDCl meetings and weekly CAPA meetings.
- Conducting review of eBR, SOP, and logbooks as per GMP guidelines.
- Participating in deviation investigations and assist in preparing DCFs.
- Participating in HSE checks and inspections and follow safety procedures.
- Assisting and performing implementation of facility, equipment, and process improvement projects.
- Performing execution and writing of documents (specifications, protocols and reports) related to facility, equipment, and process improvement of production process.
- Modification of SOPs and BPRs for new processes in accordance with change control policies.
- Performing IQ, OQ, and PQ for new equipment.
- Assisting with implementation of corrective actions in production.
- Preparing Qualification forms, test scripts, and reports as part of change controls and executing various test scripts on the equipment for PQ.
- Managing the equipment master in B100 upstream and handling user access requirements and routine backing up of data.
- Conducting EDPR (Electronic data periodic reviews) on bench top equipment and ensuring data integrity.
- Archiving logbooks, protocols and batch related documents as required.
Technologist/ CQ Owner
Sanofi Pasteur Limited
06.2021 - 05.2024
- Conducted and performed engineering and PPQ runs of cP, Diphtheria, and Tetanus batches.
- Performed seed inoculation, purity testing, grams staining, and prepared samples for Bradfords, Iron, Maltose, Glucose, and SDS-PAGE in accordance with engineering and PPQ protocols and electronic batch record (eBR) requirements.
- Experience in managing small teams on the shop floor for training on processes and equipment.
- Completed execution of 100+ IV, start-up and shakedown (SUSD) and operation verification (OV) commissioning test scripts (CTSs) for Component walk-downs as per P&IDs, slope verification, loop checks, Pressure control, utility introduction, Functional specification verification, Transfer verification, CIP and SIP cycle development, and temperature control verification on various skids i.e 3cP, Diphtheria, and Tetanus facility.
- Experience in troubleshooting and problem-solving and conducting various tests on process equipment such as Microfiltration skids, FIM Ultrafiltration skids, centrate tanks, extraction tanks, Heat treatment tank and fermentors.
- Experience in operating and troubleshooting manufacturing automation (Delta V) systems and Manufacturing execution systems (MES).
- Experience in working with Filter Integrity Tester, MAS Air Sampler, Met One Particle Counter, Tube Welder/Sealer, and Tachometer during CQ&Q and engineering runs.
- Proficient in operating and troubleshooting Type 1 and Type 2 systems and optimizing book reviewer
- Equipment requalification and validation
- Administrator for bench top equipment
- Completed 100+ Commissioning test script
- Leadership
- Troubleshooting Delta V and PLC
- Health and safety member
- Production of Component Pertussis(cP), Diphtheria, and Tetanus
- Continuous improvement
- Trainer for production technique and SOPs
Processing Specialist
Krispy Kreme
06.2020 - 12.2021
- Joint Health and Safety Committee member.
- Trained new members on process and gave feedback on the quality of the operations.
- Managed production and assessed and maintained the quality of the doughnuts.
- Inspected all products for quality and removed imperfect doughnuts and baked goods, Checked HACCP and maintained safety at the workplace.
- Minimized waste by proper storage and production planning procedures.
- Complied with all safety and sanitation (including handwashing) guidelines and procedures.
Research Project Assistant (contract)
Centennial College
03.2021 - 04.2021
- Conducted literature reviews and collected and analyzed data.
- Identified all consumables present in the biotech labs and Categorized consumables.
- Prioritized the routine testing of laboratory instruments, calibration of analytical balances and ensured the proper functioning of emergency shower stations.
- Determined waste generation from consumable usage.
- Assisted lead researcher to change and improve the SOP when required.
- Prepared findings for publication and assisted in laboratory analysis, quality control, and data management.
Quality Assurance Associate (Internship)
Merit Bio Labs
07.2019 - 11.2019
- Unpacked, sorted, and packed a variety of samples.
- Collected field samples and conducted technical analysis on the quality of the products.
- Prepared media and samples for the analysis.
- Routinely carried out environmental monitoring and maintained LIMS record systems to track quality data.
- Operated HPLC, Gas chromatography, Column chromatography, and various microbial enumeration techniques.
- Ensured products met quality standards and identified non-conformities.
- Initiated deviations and implemented corrective action to resolve issues as directed by the supervisor.
- Accurately recorded test results in a timely manner and compiled testing and lab reports.
- Organized QA plans and performed quality control testing.
Undergraduate Student Researcher
Kristu Jayanti College
07.2018 - 06.2019
- Collected samples, taking measurements, planning, and carrying out trials.
- Grew microbe cultures for the research purpose.
- Conducted literature reviews, and data collection and analyse of data, Familiar with data management software.
- Prepared materials for submission to granting agencies and foundations
- Provided ready access to all experimental data for the faculty researcher and/or supervisor.
- Requested or acquired equipment or supplies necessary for the project
- Published articles in international journal of pharmaceutical science.
- Managed laboratories, Observed high health and safety standards.
Education
Master's - biotechnology
University of Guelph
Post Graduate Advanced Diploma - Biotechnology
Centennial College
Bachelor's - Biotechnology, Biochemistry and Genetics
Kristu Jayanti College
Skills
- Equipment management
- Problem-solving
- Multitasking
- Teamwork
- Time management
- Effective communication
- Decision-making
- Project leadership
- Analytical thinking
- Vendor coordination
- Technical writing
- Project coordination
- Data backup and recovery
- Commissioning and qualification owner
- CAPA Support
- Change control leader
- Electronic batch record and log book reviewer
- Equipment requalification and validation
- Administrator for bench top equipment
- Completed 100 Commissioning test script
- Leadership
- Troubleshooting Delta V and PLC
- Health and safety member
- Production of Component Pertussis(cP), Diphtheria, and Tetanus
- Continuous improvement
- Trainer for production technique and SOPs
- System administration
- Strategic planning
- Quality control and assurance
- Equipment operation
- Equipment functional improvement
- Fast learner
- Teamwork and collaboration
- Critical thinking
- Project management
- Validation protocols
- Six sigma methodologies
Certification
- Food Safety Management System (FSMS)-ISO 22000:2018 Internal Auditor, 2018, International Institute for Certification and Training, India
- Quality Assurance / Quality Controller Certification Training, 2019, PVT Meri Bio labs, Kochi, India
https://www.linkedin.com/in/sharon-biotechnologist/
Timeline
Technical Administrator
Sanofi Pasteur Limited
05.2024 - Current
Technologist/ CQ Owner
Sanofi Pasteur Limited
06.2021 - 05.2024
Research Project Assistant (contract)
Centennial College
03.2021 - 04.2021
Processing Specialist
Krispy Kreme
06.2020 - 12.2021
Quality Assurance Associate (Internship)
Merit Bio Labs
07.2019 - 11.2019
Undergraduate Student Researcher
Kristu Jayanti College
07.2018 - 06.2019
Post Graduate Advanced Diploma - Biotechnology
Centennial College
Bachelor's - Biotechnology, Biochemistry and Genetics
Kristu Jayanti College
Master's - biotechnology
University of Guelph
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