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Quality Assurance Specialist

2 months ago

Charing Cross, United Kingdom SKC Recruitment Ltd Full time
Job Title: Quality Assurance Specialist

We are seeking a highly skilled Quality Assurance Specialist to join our team at SKC Recruitment Ltd. As a Quality Assurance Specialist, you will play a critical role in ensuring the safe distribution of medicinal products and safeguarding patient safety.

Key Responsibilities:
  • Ensure all activities follow relevant company standard operational procedures and guidelines.
  • Manage product quality complaints and related product sample returns from patients.
  • Support, maintain, and identify opportunities for improving the eQMS, including acting as system administrator.
  • Assist in dealing with drug alerts and product recalls.
  • Work closely with business functions to facilitate actions and maintain compliance to current procedures.
  • Assist with the evaluation of GxP non-conformance using quality tools and techniques.
  • Support with managing and maintaining Quality Risk Assessments.
  • Analyse performance data to identify quality trends and assist with the preparation of Quality KPI metrics.
  • Assist with managing suppliers and client qualifications.
  • Play an active role in internal and external audits.
Person Specification:
  • Understanding of critical importance of maintaining quality standards.
  • Basic understanding of GDP/GMP principles and guidelines.
  • Experience of Quality System processes, including Audit, Deviations, CAPA, Change Control, and Risk Assessments.
  • Ability to articulate and implement SOPs & quality documents.
  • Computer literate with knowledge of Microsoft packages.
  • Educated to degree level in Life Sciences or equivalent.
  • Experience in quality assurance and regulatory compliance ideally within the pharmaceutical environment.