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Regulatory Compliance Officer

2 months ago

Brampton, Ontario, Canada SUN PHARMA Full time

About the Role

The Senior Analyst, Quality Control position plays a critical role in ensuring the highest quality of products manufactured, packaged, or tested at the Taro manufacturing facility. This position is 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 and Canadian and FDA cGMP and HS&E requirements.
  • Identify and implement key process improvements to enhance systems, gain site efficiencies, and elevate GMP requirements.

Development Focus

  • Lead the development and validation of methods within the QC lab for HPLC and other instrumental techniques, with the goal of updating and improving existing methods.
  • Development and validation of cleaning validation methods as required.
  • IV drug release testing for product comparison.
  • Process validation and cleaning validation testing.
  • Method transfer activities.
  • New product introduction.
  • Product, method, and raw material troubleshooting.
  • Lead projects in the area of focus related to process improvement.
  • With the Quality Control Supervisor, lead meetings to determine priorities, coordinate the workload, and communicate and seek agreement with the team on group priorities.
  • Act as a subject-matter-expert and provide technical assistance, coaching, and guidance to the team.