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