Title: 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, 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

Physical requirements

Office based

Direct reports

NA