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Senior Quality Assurance Specialist

2 months ago

Borehamwood, Hertfordshire, United Kingdom Macstaff Full time

About Macstaff

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

The Role

The Senior Quality Assurance Associate will join Macstaff's Quality Team at their Head Office, working in a diverse range of products, suppliers, and customers, both UK and international. This role is ideal for a Senior Quality Assurance Associate with experience in a GDP environment seeking to develop towards the position of RP/RPi on the WDA (H).

Key Responsibilities

  • Manage day-to-day excursions, deviations, CAPA's, change controls, and risk mitigation
  • Develop SOPs, manage temperature excursions, and KPIs
  • Qualify new customers and suppliers
  • Review and make decisions on medicines licensed in the UK but manufactured in the EEA
  • Support product approvals
  • Plan internal and external audits
  • Understand and support validation activities, perform risk management activities, and support route qualification activities
  • Work closely with the RP/RPi, and work towards becoming an RP, engaging in research, learning, and training to enhance 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 You'll Get

As a Senior Quality Assurance Associate, you will enjoy a highly competitive salary, bonus, and package.