Senior Quality Assurance Associate

Cure Talent
Sevenoaks
4 days ago
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Cure Talent is thrilled to partner with a leading Pharmaceutical CDMO who, due to their exceptional continued growth, have an exciting opportunity for a Senior Quality Assurance Associate to join their team.


In this role, you will take a lead in maintaining and developing the Pharmaceutical Quality System across UK and Ireland operations. You will provide specialist QA support across the full range of Quality Systems, including deviations, CAPA, change control, validation, supplier audits, and document control. You’ll also play a key role in hosting audits, training QA Officers, and supporting cross-functional teams to ensure operational compliance with GMP and GDP regulations.


Key Responsibilities:

  • Maintain and develop the company’s global PQS in line with current regulations and internal standards
  • Oversee core PQS elements including change controls, CAPAs, deviations, complaints, document control, and risk management
  • Provide QA support for validation, environmental monitoring, and technical documentation
  • Review and approve batch records, QC test data, and finished product specifications
  • Support and host internal, supplier, and regulatory audits
  • Mentor and train QA Officers, delivering internal training on GMP and GDP requirements
  • Collaborate with production and technical teams to ensure compliance across manufacturing, storage, and distribution
  • Contribute to management reviews and present KPIs on Quality System performance


What You Will Need:

  • Proven experience in QA within a GMP-regulated pharmaceutical environment
  • Strong knowledge of PQS management, including quality systems such as CAPA, change control, and deviations
  • Experience supporting audits, document control, and product quality reviews
  • Excellent team leadership, communication, and problem-solving skills
  • A scientific degree (e.g. Chemistry, Pharmaceutical Sciences) or equivalent relevant experience
  • Experience working with sterile and non-sterile products highly desirable
  • Internal or Lead Auditor qualification preferred


If you are passionate about Quality Assurance and want to work in a dynamic and collaborative pharmaceutical setting, we would love to hear from you!

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