Senior Quality Assurance Specialist

6 days ago


Watford, Hertfordshire, United Kingdom Macstaff Full time £45,000
About the Role

We are seeking a highly skilled Senior Quality Assurance Specialist to join our Quality Team at Macstaff's Head Office in Elstree, Hertfordshire. This is a fantastic opportunity for a motivated and experienced professional to take on a challenging role and contribute to the success of our company.

Key Responsibilities
  • Manage and investigate excursions, deviations, CAPAs, change controls, and risk mitigation strategies 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 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 quality and compliance.
  • Collaborate with the Regulatory Affairs team to understand and support validation activities, risk management, and route qualification.
Requirements
  • Proven experience in Quality Assurance, with a strong background in GDP compliance.
  • Proficient in MS Office and able to present and train colleagues.
  • Experience in conducting internal and external audits.
  • Strong analytical and problem-solving skills.
What We Offer

As a Senior Quality Assurance Specialist at Macstaff, you will enjoy a competitive salary, bonus, and benefits package.



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