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Senior Quality Assurance Associate

2 months ago


Borehamwood, Hertfordshire, United Kingdom Macstaff Full time

Job Summary

We are seeking a highly skilled Senior Quality Assurance Associate to join our Quality Team at Macstaff's Head Office in Elstree, Hertfordshire. As a key member of our team, you will be responsible for ensuring the highest standards of quality and compliance in our global pharmaceutical distribution business.

Key Responsibilities

  • Manage and investigate excursions, deviations, CAPAs, change controls, and risk mitigation to ensure compliance with GDP regulations.
  • Develop and implement Standard Operating Procedures (SOPs) for temperature excursions and KPI management.
  • Qualify new customers and suppliers to ensure they meet our quality and compliance standards.
  • Review and make decisions on medicines licensed in the UK but manufactured in the EEA.
  • Support product approvals and planning internal and external audits.
  • Understand and support validation activities, perform risk management activities, and support route qualification activities.
  • Work closely with the Regulatory Affairs team to ensure compliance with regulatory requirements.

Requirements

  • Proven experience in Quality Assurance, with a strong understanding of GDP compliance regulations.
  • Proficient in MS Office and able to present and train colleagues.
  • Experience in internal and external audits, with a strong attention to detail.
  • Ability to work in a fast-paced environment and prioritize tasks effectively.

What We Offer

  • A highly competitive salary up to £45K + Bonus + Package.
  • A comprehensive benefits package, including health insurance and pension scheme.
  • Opportunities for professional development and career growth.

How to Apply

If you are a motivated and experienced Quality Assurance professional looking for a new challenge, please submit your CV and cover letter to us.