Analyst, Quality Control Development

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