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Quality Assurance Specialist

2 months ago

Brampton, Ontario, Canada SUN PHARMA Full time
Job Title: Quality Assurance Specialist

Job Summary:

The Quality Assurance Specialist will be responsible for ensuring that all Taro products meet the company and cGMP requirements before release for sale, manufacture, or packaging. This includes reviewing laboratory-related documents, accuracy of data entries, and contributing to reports and performance metrics.

Key Responsibilities:

  • Review laboratory-related documents to ensure compliance with Taro and GMP requirements
  • Verify accuracy of data entries in BPCS and/or LIMS
  • Contribute to reports and performance metrics
  • Automate job functions to achieve efficiency improvements
  • Work with other departments to build quality into processes and systems
  • Complete GMP documentation correctly and in a timely manner
  • Complete training assignments and maintain personal training records
  • Participate in and/or lead Non-Conformance Investigations
  • Complete Corrective and Preventive Actions (CAPA's)
  • Initiate and follow through with actions required to close Change Controls
  • Participate in Internal, Customer, and Regulatory Audits
  • Assist personnel with documentation issues and provide coaching and guidance to the Quality Control team
  • May be required to deliver technical training programs
  • Participate in activities supporting Laboratory Investigations
  • Provide support for Regulatory Inspections
  • Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements

Requirements:

  • B. Sc. (Chemistry or Microbiology) or equivalent experience required
  • Minimum 5 years experience with quality control laboratory background in pharmaceutical industry
  • Quality Assurance and audit background in pharmaceutical industry would be an asset
  • Proficient knowledge of applicable instruments (HPLC, GC experience preferred)
  • Multi-tasking ability

Working Conditions:

  • Generally pleasant conditions, with occasional exposure to higher than normal noise levels
  • Desk work with a mixture of standing and walking, and some light lifting
  • Ability to work under stressful conditions and prioritize workload