Pharmaceutical Quality Manager

2 weeks ago


Oslo, Oslo County, Norway PharmEng Technology Full time

Overview

The Quality Assurance Consultant is responsible for ensuring the implementation, maintenance, and oversight of the Quality Management System (QMS) in local affiliates. This role ensures compliance with regulatory requirements, quality standards, and company policies.

Responsibilities

  • Implementing and maintaining a Quality Management System (QMS)
  • Ensuring adherence to 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

Skills and Qualifications

  • 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)


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