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Senior Quality Assurance Specialist

2 months ago

Brampton, Ontario, Canada SUN PHARMA Full time

About the Role

The Senior Quality Assurance Specialist will play a key role in ensuring the quality of our products and processes at Taro Pharmaceuticals, a leading provider of specialty pharmaceuticals. As a member of the Quality Control team, you will be responsible for leading activities towards the maintenance of a site-wide quality program that meets Taro, Canadian, and FDA cGMP requirements.

Key Responsibilities

  • Lead a team of analysts to conduct GMP laboratory testing, providing coaching, subject-matter-expertise, and technical mentorship.
  • Lead the roll-out of new laboratory requirements, business operations, processes, and technologies to the analyst team.
  • Provide troubleshooting of test method and equipment issues.
  • Responsible for the full-cycle of internal lab investigations, including trending and preventative actions.
  • Technical training of Analysts in analytical methods, as well as on-boarding of new employees.
  • In-process, bulk, FG, Stability, validation/verification, and investigation sample testing.
  • Method transfer activities.
  • With the Quality Control Supervisor, lead meetings to determine priorities, coordinate the workload, and communicate and seek agreement with the team on group priorities.
  • Provide support for internal and regulatory inspections.
  • Recommend, design, and deliver training targeted to ensuring technical capability of the team, as well as compliance with SOPs & Canadian and FDA cGMP and HS&E requirements.
  • Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements.

Requirements

  • Strong leadership and communication skills.
  • Experience in quality control and assurance, preferably in the pharmaceutical industry.
  • Knowledge of cGMP regulations and guidelines.
  • Ability to lead and motivate a team.
  • Strong analytical and problem-solving skills.

About Us

Sun Pharma is a leading global pharmaceutical company with a commitment to providing high-quality healthcare products. We are dedicated to meeting the needs of our customers and the overall community through innovation, development, manufacturing, and marketing of the highest quality healthcare products.