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Compliance Operations Specialist

1 week ago

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

Job Summary:

Sun Pharmaceutical Industries, Inc. is a leading global pharmaceutical company with a strong presence in the generics market.

We are seeking a highly skilled Compliance Associate II to join our team in ensuring site compliance to cGMP regulations and internal quality procedures.

The ideal candidate will have a minimum of five years of experience within the pharmaceutical industry in quality function roles, with expertise in software applications such as MS Word, Excel, and TrackWise.

Key Responsibilities:

  • Maintaining the Global Documents implementation tracker and communicating with the Global corporate team.
  • Performing gap assessments and managing the implementation of global procedures at site by coordinating with cross-functional teams.
  • Reviewing and approving Action Items, CAPAs, and Global CAPAs in TrackWise and monitoring their effectiveness.
  • Conducting annual cGMP training programs for the site and initial acknowledgement and classification of site deviations in TrackWise.
  • Assisting in ensuring FDA Readiness Plans for facilities and providing support for all regulatory audits, internal/external inspections, and other audits.

Requirements:

  • Minimum Bachelor's degree.
  • Demonstrated ability and knowledge of QMS and driving investigations to completion.
  • Thorough understanding of GMPs and expertise in software applications.
  • Strong knowledge of project management principles and excellent interpersonal and communication skills.
  • A self-starter with hands-on approach and can-do attitude.
  • Intermediate-B1+ level English language proficiency based on CEFR.

About Us:

Sun Pharma is committed to delivering high-quality medicines to patients worldwide while maintaining compliance with regulatory requirements.

We offer a dynamic work environment with opportunities for professional growth and development.