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Quality Assurance Lead

2 months ago

Watford, Hertfordshire, United Kingdom Macstaff Full time

Job Summary

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 regulatory requirements.
  • Develop and implement Standard Operating Procedures (SOPs) for temperature excursions and KPI management.
  • Qualify new customers and suppliers to ensure 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 to ensure compliance with regulatory requirements.
  • Understand and support validation activities, and 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 focus on GDP compliance.
  • Proficient in MS Office and other relevant software.
  • Excellent communication and presentation skills.
  • Experience in conducting internal and external audits.

What We Offer

We offer a highly competitive salary, bonus, and benefits package to successful candidates.