Quality Assurance Lead

1 week ago


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

At MacStaff, we are seeking a highly skilled Senior Quality Assurance Associate to contribute to our global pharmaceutical distribution firm's commitment to ensuring GDP compliance from our headquarters. Our company prioritizes emerging markets, partnering with innovative companies to deliver their products to regions they cannot reach, and is renowned for quality in time-critical, temperature-controlled supply chain and logistics.

This is a challenging and interesting workplace with a diverse range of products, suppliers, and customers, both domestic and international, from pharmacies to wholesalers to hospitals.

Key Responsibilities:
  • Day-to-day management of excursions, deviations, CAPAs, change controls, and risk mitigation
  • SOP development, temperature excursions, and KPI management
  • Qualification of new customers and suppliers
  • Reviewing and making decisions on medicines licensed in the UK but manufactured in the EEA
  • Supporting product approvals
  • Planning internal and external audits
  • Understanding and supporting validation activities, performing risk management activities, and supporting route qualification activities

As a Senior Quality Assurance Associate, you will work closely with the Regulatory Affairs team and engage in research, learning, and training to enhance your knowledge and capability.

Requirements:
  • Quality Assurance experience
  • GDP compliance environment
  • Proficient PC skills across MS Office
  • Ability to present and train colleagues
  • Experience doing internal and external audits
What We Offer:
  • A highly competitive salary up to £45K + Bonus + Package


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