Title: Analyst, Quality Control Development
Date:
Oct 3, 2025
Location:
Sun Pharma Canada Inc.
Company:
Sun Pharma Canada Inc.
Job purpose
The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.
Duties and responsibilities
- Perform Assay and Related Substances method development and validation study using HPLC, GC and other instrumental techniques.
- Ensure timely completion of routine analysis for bulk, finished products, exhibit batches, and stability samples.
- Prepare protocol, test method and report related with method validation and method transfer studies.
- Conduct method verification, compendial update & method transfer activities.
- Identify and implement key process improvements to enhance systems, improve efficiency, and meet GMP requirements.
- Ensure Out-of-Specification (OOS), Out-of-Trend (OOT), and Corrective and Preventive Actions (CAPAs) are completed within defined timelines.
- Collaborate cross-functionally to proactively build quality into processes and systems.
- Create and revise Quality Control (QC) procedures as required.
- Provide support during internal and regulatory Inspections.
- Generate, compile and analyze data for reporting purposes.
- Complete all GMP documentation correctly and in a timely manner.\Initiate and follow through on actions required to close change controls.
- Participate in Internal, customer and regulatory audits.
- Maintain a clean and safe laboratory environment, adhering to all safety regulations.
- Complete all assigned training and maintain up-to-date personal training records.
- Demonstrate flexibility to work shift schedules as required.
- Support peer review of analytical data.
- Contribute to new product launches.
- Perform other duties as assigned by the manager.
Additional responsibility (Only applicable to customer facing roles)
Report any adverse event received from customers for company products to the pharmacovigilance department / Drug Safety on the same day or within 1 business day
Qualifications
- Bachelor’s Degree in Chemistry or a related discipline (minimum requirement).
- 5-7 year of experience in Assay & Impurities method validation in a pharmaceutical laboratory.
- Expert knowledge of analytical chemistry and instrumentation.
- Proficiency in analytical techniques such as UV-Vis, IR, HPLC and GC.
- Familiarity with software systems including LIMS, Empower, and Microsoft Office.
- Strong understanding and application of Health Canada and FDA regulations.
- Excellent written communication and report writing skills.
- Advanced troubleshooting and investigative skills for analytical issues.
- Ability to recommend changes and initiate investigations when necessary.
- Recommends changes and requests investigations where required.
- Knowledge of In-Vitro & Cleaning validation study is considered an asset
Working conditions
- Ability to work under stressful conditions and changing priorities
- Ability to support work in other shifts
- Numerous and varied responsibilities demanding attention and detail
- Working in general office and laboratory environments
Physical requirements
Office based