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Senior Quality Assurance Specialist
2 months ago
About the Role
We are seeking a highly skilled Senior Quality Assurance Associate to join our Quality Team at Macstaff's Head Office in Elstree, Hertfordshire. This is an exciting opportunity for a professional with experience in Quality Assurance within a GDP environment to develop their skills 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 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, 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 within a GDP environment.
- Proficient in MS Office and able to present and train colleagues.
- Experience in conducting internal and external audits.
- Strong analytical and problem-solving skills.
- Ability to work in a fast-paced environment and prioritize tasks effectively.
What We Offer
As a Senior Quality Assurance Associate at Macstaff, you will enjoy a highly competitive salary, bonus, and benefits package.
