DARSHAN SONI
Etobicoke,ON
Summary
Dedicated, motivated and reliable Quality Assurance Technician with a proven ability to complete tasks with optimal efficiency, accuracy and while adhering to protocol standards. Seeking employment opportunity to further expand skillset. Exceptional proficiency in learning new concepts, working well under pressure and an ability to communicate ideas clearly and with focus.
Overview
8
8
years of professional experience
Work History
Quality Assurance In-Process Technician
Apotex Inc.
01.2022 - Current
- Providing Quality Assurance support and oversight of Manufacturing Processing areas, through Shop Floor engagement (Floor Presence, Functional Area Audits, Compliance Meeting participation, Online batch record review)
- Providing Guidance to production personnel to help resolve LIMS or documentation issues
- Responsible for the execution of quality checks (startup approval, in process and end of batch checks, AQL inspections of finished or semi-finished products and Special Testing Request (STR)
- Providing immediate direction for potential quality issues on the shop floor including first assessment of potential deviations and initial determination of product impact, containment, immediate corrective actions and escalation
- Performing verification of potency calculation of Master Manufacturing Record as required
- Responsible to perform regular assessments of manufacturing areas to ensure all activities performed in the area are in full compliance with GMPs, SODs and established safety standards
- Ensure all observations are addressed in a timely manner
- Auditing logbooks used in the manufacturing areas for completeness and GMP compliance
- Experienced in using SAP to generate inspection instructions, print labels and documents, quarantine investigation containers as well as reviewing maintenance notifications etc
- Trained for LIMS to perform in-process checks of solid dosage (such as weight variation, hardness/thickness, and friability) as well as to review overall results during documentation review
- Liaised with internal departments to optimize productivity and efficiency.
- Participated in Kaizen activity for QAIP shift preparation and GMP walkthroughs
- Initiating waste disposal of solid dosage remnants as well as controlled substance waste using TrackWise.
Production Technician
Apotex Inc.
07.2017 - 12.2021
- Performed all duties according to established SOD’s, GMP’s and safety standards
- Thorough knowledge of documentation as per SOD, GDP and GMP requirements (i.e., Potency calculations, observations, batch record information etc.)
- Trained to setup, operate, troubleshoot and dismantle pharmaceutical grade equipment (i.e., Quadro comil, Q-VAC, Russell Finex)
- Performed complex dispensing batch execution accurately according to batch document instruction on paper as well as using POMSnet batch execution system
- Conducted in-process sampling as required by the batch documents
- Trained to execute Controlled Substances dispensing batches according to established SODs and batch instructions
- Achieved department changeover and dispensing targets effectively while meeting GMP compliance
- Trained/assessed production personnel to execute manufacturing batches using POMsnet
- Actively participated in regulatory audit preparation and new product launch campaigns
- Volunteered as a spill responder and AQPIC for controlled substances
Equipment Sanitation Technician
Patheon Inc
10.2016 - 07.2017
- Followed GMP while working inside the production area
- Dismantled and cleaned equipment including SS Drums, Totes, Vac-U-Max, Screens and Plastic drums/lids as well as other production equipment as required
- Followed step-by-step SOPs for cleaning and sanitizing all equipment
- Managed detergents and cleaning agent’s inventory
- Performed other duties as required in different departments such as quality inspection of tablets, assisting material loading in production line and packaging shippers.
Education
Ontario College Diploma - Industrial Pharmaceutical Technology
Seneca College of Applied Arts And Technology
North York, ON04.2026
Ontario College Diploma - Chemical Laboratory Technician
Durham College
Oshawa, ON04.2016
Bachelor of Science - Pharmacy
Gujarat Technological University
Gujarat, India08.2014
Skills
- Data Analysis & Interpretation
- LIMS
- SAP
- Trackwise
- MS Word, Excel, Powerpoint, Database
- Certified POMsnet Trainer/Assessor
- AQPIC for CS activity
- Quality Inspection (AQL, Investigational AQL)
- Certified Lean Six Sigma white belt (pursuing yellow belt)
- Troubleshooting process/equipment
- Investigation support
- Multitasking and Organization
- Attention to Detail
References
REFERENCE ON REQUEST
Timeline
Quality Assurance In-Process Technician
Apotex Inc.
01.2022 - Current
Production Technician
Apotex Inc.
07.2017 - 12.2021
Equipment Sanitation Technician
Patheon Inc
10.2016 - 07.2017
Ontario College Diploma - Industrial Pharmaceutical Technology
Seneca College of Applied Arts And Technology
Ontario College Diploma - Chemical Laboratory Technician
Durham College
Bachelor of Science - Pharmacy
Gujarat Technological University
Similar Profiles
Shrey PatelShrey Patel
Production Technician at APOTEX INC.Production Technician at APOTEX INC.
GAVIN THOMAS PULIYODILGAVIN THOMAS PULIYODIL
Production Technician at Apotex Inc.Production Technician at Apotex Inc.
VIVEK VINAYAKUMARVIVEK VINAYAKUMAR
Pharmaceutical Production Technician at APOTEX INC.Pharmaceutical Production Technician at APOTEX INC.