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Senior Quality Assurance Specialist

2 months ago


East Anglia, United Kingdom Macstaff Full time £45,000
About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Macstaff. As a Senior Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our products and services.

Key Responsibilities
  • Manage and investigate excursions, deviations, CAPAs, change controls, and risk mitigation strategies to ensure compliance with GDP regulations.
  • Develop and implement SOPs, temperature excursion protocols, and KPI management systems to maintain high-quality standards.
  • Qualify new customers and suppliers to ensure they meet our quality and compliance requirements.
  • Review and make decisions on medicines licensed in the UK but manufactured in the EEA, ensuring compliance with regulatory requirements.
  • Support product approvals and planning internal and external audits to ensure quality and compliance.
  • Understand and support validation activities, perform risk management activities, and support route qualification activities.
  • Work closely with the RP/RPi and engage in research, learning, and training to enhance knowledge and capability.
Requirements
  • Proven experience in quality assurance, with a strong background in GDP compliance.
  • Proficient PC skills across MS Office, with the ability to present and train colleagues.
  • Experience conducting internal and external audits, with a strong understanding of regulatory requirements.
What We Offer

As a Senior Quality Assurance Specialist at Macstaff, you will enjoy a highly competitive salary, bonus, and package, as well as opportunities for professional growth and development.