Quality Assurance Specialist

1 week ago


Borehamwood, Hertfordshire, United Kingdom MacStaff Full time
Senior Quality Assurance Associate

**About the Role**

MacStaff is seeking a highly skilled Senior Quality Assurance Associate to join our team at our Head Office in Elstree, Hertfordshire. As a key member of our Quality Team, you will play a vital role in ensuring GDP compliance and contributing to the success of our global pharmaceutical distribution firm.

**Key Responsibilities:**

  • Manage and resolve excursions, deviations, CAPAs, change controls, and risk mitigation on a daily basis.
  • Develop and implement Standard Operating Procedures (SOPs), manage temperature excursions, and track Key Performance Indicators (KPIs).
  • Qualify new customers and suppliers, ensuring they meet our quality standards.
  • Review and make decisions on medicines licensed in the UK but manufactured in the EEA.
  • Support product approvals and ensure compliance with regulatory requirements.
  • Plan and conduct internal and external audits, ensuring our quality systems are robust and effective.
  • Understand and support validation activities, perform risk management activities, and support route qualification activities.

**Requirements:**

  • Proven experience in Quality Assurance, particularly in a GDP compliance environment.
  • Proficient in MS Office and able to present and train colleagues effectively.
  • Experience conducting internal and external audits, with a strong understanding of regulatory requirements.

**What We Offer:**

  • A highly competitive salary up to £45K + Bonus + Package.

**About MacStaff**

MacStaff is a global pharmaceutical distribution firm that prioritizes emerging markets and partners with innovative companies to deliver their products to regions they cannot reach. We are renowned for our quality in time-critical, temperature-controlled supply chain and logistics.



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