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Quality Assurance Specialist

2 months ago

Milton Keynes, Milton Keynes, United Kingdom Proclinical Staffing Full time
Job Description

Proclinical Staffing is seeking a dedicated Quality Technician III to perform microbiology testing, isolator and clean room testing, and investigations for deviations.

Key Responsibilities:
  • Perform and oversee testing of intermediate and finished products in compliance with Good Manufacturing Practices (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.
Requirements:
  • 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.