Quality Assurance Specialist

4 weeks ago

Brampton, Ontario, Canada SUN PHARMA Full time

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 role requires a strong understanding of Health Canada and FDA regulations, as well as excellent written communication and report writing skills.

Key Responsibilities

  • Review all laboratory related documents to ensure that Quality Control Laboratory: finished products, bulk, raw material stability, and Microbiology meet Taro and GMP requirements prior to release
  • Review accuracy of data entries in BPCS and/or LIMS
  • Contribute and generate reports / performance metrics and data
  • Automate job functions to achieve efficiency improvements
  • Work with other departments to proactively build quality into the processes and systems
  • Complete all GMP Documentation correctly and in a timely manner
  • Complete all 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 provides coaching and guidance to 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 areas to enhance systems, gain site efficiencies and elevate GMP requirements.

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