Quality Assurance Specialist

6 days ago


High Wycombe, Buckinghamshire, United Kingdom Proclinical Staffing Full time
Job Description

**Job Summary:**

Proclinical Staffing is seeking a dedicated Quality Technician III to perform microbiology testing, isolator and clean room testing, and investigations for deviations. This role involves testing finished products and intermediates in accordance with Good Manufacturing Practices (GMP), dossier, and relevant pharmacopoeia requirements.

Key Responsibilities:

  • Perform and oversee testing of intermediate and finished products in compliance with GMP and pharmacopoeia requirements.
  • Conduct microbiology testing and train personnel on procedures such as bioburdens, water testing, plate reading, sterility testing, growth promotion, and inactivations.
  • Ensure all activities comply with GMP, quality guidelines, and pharmacopeia standards.
  • Raise deviations in the Quality Management System.
  • Facilitate change management by managing change controls and actioning tasks in the Quality Management System.
  • Complete and review COSHH assessments and risk or manual handling assessments.
  • Provide training on test procedures to new team members.
  • Enter and lock test results in SAP.
  • Comply with company procedures regarding GMP and UK pharmaceutical regulations.
  • Proficiency in Quality Control testing and laboratory investigations.
  • Familiarity with MS Word and Excel.
  • Ability to identify deviations and raise events in the Quality Management System.
  • Proficient in protocol, hypothesis, and report writing.
  • Flexible approach to changing priorities and good attention to detail.


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