Regulatory Compliance Expert

2 weeks ago


Oslo, Oslo County, Norway PharmEng Technology Full time

About PharmEng Technology

Job Summary: We are seeking a highly skilled Regulatory Compliance Expert to join our team as a Quality Assurance Consultant. In this role, you will be responsible for ensuring the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates.

Key Responsibilities:

  • Implementing and maintaining a robust Quality Management System (QMS)
  • Ensuring compliance with regulatory requirements and quality standards
  • Managing quality risk and developing effective strategies to mitigate risks
  • Leading complaint resolution processes and managing deviations
  • Collaborating with cross-functional teams to implement change control procedures
  • Coordinating product quality reviews (PQR)
  • Delivering training programs to local staff
  • Ensuring GDP requirements are met for local warehousing and distribution
  • Monitoring GxP suppliers and their compliance status

Requirements

  • Bachelor's degree in Quality Management, Life Sciences, or a related field
  • Minimum of 5 years of experience in Quality Assurance within the pharmaceutical or healthcare industry
  • Strong knowledge of GxP regulations and quality standards
  • Excellent analytical, problem-solving, and communication skills
  • Ability to work independently and collaboratively in a team environment
  • Proficiency in using Quality Management Systems and Learning Management Systems (LMS)

About Us

PharmEng Technology is a leading provider of pharmaceutical solutions. Our team is passionate about delivering high-quality products and services to our clients.



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