Quality Assurance Specialist

2 weeks ago


Marlow, United Kingdom CK Group Full time
Job Description

CK Group is seeking a highly skilled Quality Assurance Officer to join their team on a contract basis for 5 months. The successful candidate will be responsible for providing day-to-day assistance for commercial QA activities, including maintenance of quality systems, deviation reporting, change control, and quality metrics reporting.

Key Responsibilities:
  • Quality Assurance: Assist in the maintenance of quality systems, including deviations, exception reporting, change control, supply agreements, document control, and quality metrics reporting.
  • Record Keeping: Complete scheduled records and quality system tasks in compliance with internal standards and EU GMP.
  • Quality Risk Management: Participate in Quality Risk Management (QRM) assessments.
  • Product Quality Review: Compile and review product quality review sets for completeness and compliance to EU GMP, internal requirements, and regulatory dossier submissions.
Requirements:
  • Education: Hold a degree in a relevant scientific subject or have equivalent working experience.
  • Experience: Previous working experience in a quality-based role, preferably in the pharmaceutical or manufacturing industry.
  • Knowledge: Good knowledge of GMP environments and basic experience in quality-administered systems.
About the Company:

Our client is a world-renowned innovative biopharmaceutical company, discovering, developing, and providing over 160 different medicines, vaccines, and consumer healthcare products to improve the lives of millions of people worldwide.



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