Administration & Secretarial, Fulltime, Permanent

Quality Assurance Lead


Duties & Responsibilities:

  • Maintain an overview of all aspects of the PQS to ensure its suitability and effectiveness and ensure non-compliance issues are addressed.
  • As part of the Quality Assurance Team you will be accountable for up to 5 Key Quality Process such as: CAPA, Recall, Regulatory Updates, Complaints, Deviations, Change Control, Trends, Environmental Monitoring, Supplier Assurance, Stability, Documentation, Quality Metrics, Audit & Inspection, Quality Risk Management, Data Integrity and Validation.
  • Produce regular reports detailing the status of the PQS for dissemination to the Head of Quality, QA Manager, Production Management, Managing Director and Audit/Risk Committee.
  • Escalation of issues to the Head of Quality / QA Manager.
  • Generation and GMP approval of key documentation within the PQS.
  • Conduct internal audits of the PQS as per the defined audit schedule.
  • Assist with periodic Regulatory GMP/ GDP Inspections and site preparation.
  • Lead and assist internal audits and inspections by clients.
  • Lead or take part in gap analysis, risk assessments and risk management.
  • Drive the timely implementation of risk-based changes and manage quality led improvement projects.
  • Lead investigations to determine root cause and identify effective CAPA
  • Ensure that SOPs are complied with and processes and procedures kept current.
  • Maintain awareness of changes to quality regulations and guidelines, participating in the assessment of any business implications of these changes.
  • Identify and deliver training on GxP topics and Quality Management System processes.
  • Participate in the out of hours rota system for monitoring the environmental status of the building and its equipment.
  • Undertake continuing professional development and attend any suitable training and update courses as deemed necessary and ensure a high level of competency is achieved.
  • Ensure compliance with COSHH and Health and Safety regulations and departmental SOP’s.


  • You will have previous experience in a QA role, experience in a Sterility role would be an advantage
  • You will have led QA related Improvement Activities
  • You will have proven problem-solving skills
  • You will have confident risk management
  • You will have excellent attention to detail
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