RONAK CHUNARA
Scarborough,Canada
Summary
Have an experience of LIMS software. Effectively process batches to achieve specific batch target within given time schedule. Work in adherence of current GMP, SOP and safe work practices. Calibration of laboratory equipment as per calibration program and GMP. Work as an effective team member to meet departmental goals, sharing knowledge with team members. Clean, sanitize and assemble the processing instruments to make sure it falls within GMP compliance criteria. Good verbal and written communication skills. Proficient at multi-tasking and working independently as well as in a team environment. Ability to handle stressful situations with a positive outcome.
Overview
13
13
years of professional experience
Work History
Compounder
Cosmetica Laboratories
Scarborough, ON
2025.12 - Current
- Verify batch cards against the work order before production and follow all approved manufacturing procedures.
- Report any unexpected issues or deviations to the team leader immediately.
- Perform all required in-process checks independently or with team support.
- Manufacture and color-match batches across all compounding areas.
- Complete all documentation accurately, on time, and in the correct format.
- Follow all GMP, Health & Safety, and safe-working practices to maintain a clean, compliant environment.
- Carry out all quality checks, submissions, and approvals per requirements.
- Support continuous improvement and efficiency initiatives within the department.
- Ensure all output meets organizational standards.
- Complete required training and updates; ensure equipment is properly cleaned, calibrated, and used per procedure.
- Train on new or alternate processes as directed and perform pre-weighing when required.
- Provide backup support for the Team Leader and perform other assigned duties
Filling Technician
Sanofi Pasteur
North York, Canada
2024.03 - 2024.10
- Receive goods I items from the warehouse to be autoclaved for Filling activities.
- Prepare extensions, filling and stoppering unit for the next scheduled batch.
- Prepare Stopper bags for autoclave.
- Wash and wrap hard goods in preparation for autoclaving.
- Ensure there is adequate inventory to perform cleaning & disinfection and to prepare units for filling activities.
- Safely handle acids, detergents, cleaning solutions and WFI as per as our safety guidelines.
- Operate chart recorders (Yokagawa and Chessell Chart recorder).
- Perform Vacuum Leak and Bowie Dick tests at the beginning of each operation day prior to the use of the Fedegari Autoclave.
- Autoclave hard goods, stoppers, and cleaning units using the validated cycle of the autoclave (Fedegari).
- Generate electronic reports for all autoclave cycles in the info tree.
- Setup the Vial Wash Station and Depyrogenation tunnel under Grade D Classification.
- Aseptically connect the bulk tank to the filling line through use of single actuations aseptic connections(Observed and assist).
- Depending on the configuration of the bulk tank, determine the use of recirculation pumps or pressurized nitrogen to start filling.
- Observed required environmental monitoring as outlined in the SOP.
- Transfer vial components and load into the Vial Wash station.
- Load Yokagawa Chart and Chassell Chart recorder in a timely manner prior to starting setup.
- All operators operating the vial wash station and the depyrogenation tunnel must be gowned as per Grade D classification.
- At the end of the batch, aseptically disconnect the bulk tank from the filling line.
- Clear the vial wash station, depyrogention tunnel and the filling line of components.
- Complete the post-fill disinfection of the vial wash.
- Ensure that cleaning equipment are sterile and verify that the items have not expired prior to use.
- Ensure that cleaning is performed from the highest level of classification.
- Disinfect Bulk tank during transport from Formulation to F&P and from the unclassified area into the fridge (Grade D) and documented in applicable BPR and logbook.
- Receive bulk tanks from Formulations to Filling & Packaging and maintain pressurized system of the tank if required.
Technologist
Sanofi Pasteur
North York, Canada
2023.10 - 2023.12
- Follow SOP guidelines and specifications outlined in the Batch Manufacturing Record for dispensing room setup.
- Document all setup and cleaning activities meticulously in the logbook and relevant paperwork.
- Dispense approved raw materials from the warehouse in strict adherence to SOP and Production Batch Record.
- Conduct precise formulation calculations and measurements for weight and volume, ensuring accurate release checks.
- Maintain cleaning standards as per SOP, records, and GMP regulations after each process.
- Execute SAP transactions accurately and promptly.
- Disinfect the area as stipulated in the SOP.
- Assist in maintaining cleanliness and unobstructed pathways in loading docks and hallways, ensuring proper disposal of garbage.
- Validate information on approved raw materials/packaging materials according to the Batch Manufacturing Record.
- Issue raw materials as per the Batch Manufacturing Record and record issuance details in Production Batch Record, inventory cards, and related paperwork.
- Enforce the FIFO principle for all material withdrawals.
- Verify expiry and retest dates of materials before dispensing.
- Clean the dispensing room following SOP guidelines upon completion of the dispensing process.
- Store dispensed raw and packaging materials in designated qualified warehouse locations.
- Ensure warehouse flooring and storage areas are orderly and clean.
- Conduct daily calibration procedures.
Packaging Technician
Sanofi Pasteur
North York, Canada
2023.01 - 2023.10
- Member of a team in packaging accomplishing all tasks involved in completion of assigned work orders.
- Examine (manual & Seidenader) running capper operation.
- Filling in B.P.R.'s.
- Clean machines, change webbing, set up scales (minor mechanical), record computer data entry (or other software) for measurement of line performance index.
- Troubleshoot equipment & take appropriate action to protect product.
- Attend team meetings.
- Organization of an operation including assigning people within the operation, timing of activities, ongoing planning of relief, identifying the need for assistance or overtime to maintain production.
- CGMP training, Health & Safety, gowning for packaging, SOP training, documentation training.
- Learn to operate basic labeling & packaging machines safely.
- Basic sign in on BPR, retrieve & check components to BPR.
Production Technician
Apotex Inc
Richmond Hill, Canada
2017.06 - 2022.12
- Operate different kind of machines.
- Performing all duties according to the SOD's, GMP's and all other established safety standards and company policies.
- Examine pharmaceutical products for quality while packing such as lot number, printing design, packaging material quality etc.
- Work in high pace environment on continuous basis on packaging line.
- Carry out sanitization for restricted areas of production as per SOP.
- Apply proper entry/exit procedure and PPE for clean areas of production.
- Handle and trouble-shoot problems during operation of packaging line.
- Follow strict safety and quality norm.
- Performed validation batches following protocols.
- Maintain and fill logbooks, line tracking sheet and comment log from start to end of batch.
- Set up and troubleshoot equipment for various products following SOPs and ensuring the proper selection of formats, care and use of tools, parts i.e. HMI, bottle unscrambler, labeler, cartoner, security sealer, turn table, case packer etc.
- Cleaning of equipment and production rooms as well as product contact and non-product contact parts of filling line.
- Performing good documentation throughout the batch.
- Conducting In-process check, set-up checks during production of non-sterile batches.
- Having an understand of CAPA and its implementation.
- Works as a member of a team to achieve all outcomes.
- Have an understanding and knowledge of quality checks start-up approval, in process and end of batch checks, AQL inspections.
- Experience in troubleshooting with censors and parameters so that components can move smoothly on conveyor belt.
- Participate in regularly scheduled GMP updates and safety training.
- Assists in training of new staff or existing personnel as required.
- Inspected equipment and systems to identify issues, immediately reporting problems to repair technicians.
- Calibrated machines to maintain required productivity levels and adherence to quality standards.
- Implemented updated operating procedures for machine and adjusted use to increase productivity and longevity.
- Established and managed trial projects to deploy updated processes.
Machine Operator
Alliance Labeling Inc
2016.01 - 2017.06
- Operate different kind of packaging machine.
- Check quality of labeled product.
Pharmacy Assistant Intern
PharmaSave
2015.11 - 2015.12
- Filled prescription by using pharmacy related computer software, such as Fill ware and Kroll.
- Dispensed medicines with accuracy.
- Accurately recorded compounded products and prepared appropriate labels.
- Maintained proper inventory levels, rotated stock and immediately complied with prescription drug recalls.
- Consistently upheld proper pharmacy and general safety procedures and standards.
Intern
Dupen Laboratory Pvt. Ltd
2013.06 - 2013.07
- Performed analytical testing for pharmaceutical raw materials, in-process material and finished pharmaceutical formulation, packaging material.
- Performing In process quality assurance checks for tablets, capsules and liquid orals.
- Conducted compounding and centrifugation operations.
- Inspect equipment prior to start up for changeovers, or when handing off to next shift.
Education
Bachelor of pharmacy -
Gujarat Technological University
India01.2014
Retail Pharmacy Assistant Program -
Sheridan College
Brampton, ONPost graduate diploma - Biotechnology (Industrial Microbiology)
Centennial college
ScarboroughSkills
- Good Manufacturing practices (GMP)
- Mechanical troubleshooting
- Safe Handling Procedures
- Machine operation
- Self-motivated professional
- Flexible and Adaptable
- Organization and Time Management
- Aseptic Techniques
- Attention to detail
Timeline
Compounder
Cosmetica Laboratories
2025.12 - Current
Filling Technician
Sanofi Pasteur
2024.03 - 2024.10
Technologist
Sanofi Pasteur
2023.10 - 2023.12
Packaging Technician
Sanofi Pasteur
2023.01 - 2023.10
Production Technician
Apotex Inc
2017.06 - 2022.12
Machine Operator
Alliance Labeling Inc
2016.01 - 2017.06
Pharmacy Assistant Intern
PharmaSave
2015.11 - 2015.12
Intern
Dupen Laboratory Pvt. Ltd
2013.06 - 2013.07
Bachelor of pharmacy -
Gujarat Technological University
Retail Pharmacy Assistant Program -
Sheridan College
Post graduate diploma - Biotechnology (Industrial Microbiology)
Centennial college