Analyst, Quality Control Development

Sun Pharmaceutical Industries, Inc.; Brampton; On-site; CAD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in Canada is seeking an Analyst in Quality Control Development. This role involves performing method development and validation to support the QC department. Applicants should possess a Bachelor's Degree in Chemistry and have 3-5 years of experience in a pharmaceutical laboratory. Key responsibilities include method verification, collaboration across departments, and ensuring compliance with GMP standards.

Qualifications

• 3-5 years’ method validation, verification & transfer experience in a pharmaceutical lab.
• Proficiency with analytical instrumentation like HPLC and GC.
• Sound knowledge of Health Canada and FDA regulations.

Responsibilities

• Perform method development, validation, and transfer activities.
• Ensure timely completion of all routine analyses.
• Collaborate with departments to enhance process quality.

Skills

Analytical chemistry expertise

Technical writing skills

Interpersonal skills

Organizational skills

Troubleshooting skills

Education

Bachelor's Degree in Chemistry or related discipline

Tools

HPLC

GC

LIMS

Empower

Job description

Overview

Title : Analyst, Quality Control Development

Date : Aug 25, 2025

Job purpose

The main responsibility for this position is to perform method development, validation and transfer activities to support quality control development department.

Responsibilities

• Perform Assay, Impurities, In-Vitro & Cleaning method development and validation study using HPLC, GC and other instrumental techniques.
• Ensure all routine analysis related with bulk, finished product, exhibit and stability sample are completed within deadline
• Perform method verification, compendial update & method transfer activities.
• Participate on projects in the area of focus related to process improvement.
• Collaborate with other departments to proactively build quality into the processes and systems.
• Create and revise QC procedures as required.
• Provide support for internal and Regulatory Inspections.
• Identify and implement key process improvements to enhance systems, gain site efficiencies and elevate GMP requirements.
• Generate, gather and analyze data for reporting purposes.
• Complete all GMP Documentation correctly and in a timely manner.
• Ensure OOS / OOT & CAPA’s are completed within timeline.
• Initiate, and follow through with actions required to close change controls.
• Participate in Internal, customer and regulatory audits.
• Maintain a clean laboratory environment and ensure that safety regulations are followed
• Complete all training assignment and maintain personal training records.
• Flexibility to work shift schedules when required
• Support in peer reviewing all analytical data
• Support new product launch.
• Other duties as assigned by 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 related discipline
• 3-5 years’ method validation, method verification & method transfer experience in the pharmaceutical laboratory.
• Demonstrated technical writing skills
• Well-developed interpersonal and teamwork skills
• Expert knowledge and understanding of analytical chemistry and instrumentation
• Proficiency with analytical instrumentation (pH meter, viscometer, Karl Fisher apparatus, UV-Vis, IR, HPLC, GC, UPLC etc.)
• Knowledge of applicable software including LIMS, Empower and MS Office
• Sound knowledge and application of Health Canada and FDA regulations
• Excellent written communication and report writing skills
• Strong organizational skills and ability to multi-task; detail oriented
• Advanced ability in investigative techniques to troubleshoot analytical problems
• Recommends changes and requests investigations where required.
• Any deviations to procedures or systems are brought to the Management’s attention with logic, data and corrective measures
• Knowledge of Pharmaceutical Manufacturing and Packaging would be 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