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Regulatory Compliance Specialist

2 weeks ago

Fredericton, New Brunswick, Canada Sun Pharmaceutical Industries, Inc. Full time

About the Role:

The Regulatory Compliance Specialist will be responsible for ensuring site compliance with cGMP regulations and internal quality procedures. This includes managing investigations, product quality complaints, CAPAs, deviations, and change controls. The successful candidate will ensure adherence to SOPs and policies, provide assistance during regulatory, corporate, and internal audits, and maintain the Global Documents implementation tracker.

Key Responsibilities:

  • Maintaining the Global Documents implementation tracker and updating it on a timely basis
  • Performing gap assessments and managing the implementation of global procedures at the site by coordinating with cross-functional teams
  • Assessing and reviewing site change controls in Trackwise and conducting change control review board meetings as applicable
  • Reviewing and approving Action Items, CAPA, and Global CAPA in Trackwise, and monitoring the effectiveness of CAPA
  • Conducting and leading annual cGMP training programs for the site
  • Initial acknowledgement and classification of site deviations in Trackwise on a timely manner
  • Assisting in ensuring FDA Readiness Plan for the facility and providing support for all regulatory audits, internal/external inspections, and other audits
  • Responsible for follow-ups on all related operational findings from FDA, other regulatory bodies, internal audits, etc.
  • Participating and conducting mock inspections to prepare the facility for audits and assessing gaps in the system; reviewing documents for compliance to current regulations and cGMPs
  • Identifying compliance issues and supporting the implementation of changes for constant improvements
  • Supporting adherence to SOPs and policies, and assisting in ensuring that procedures reflect current practice
  • Creating new SOPs and revising existing ones as applicable
  • Reviews and approves Qualification Protocols and Reports for equipment and product validations/verifications