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.
Requirements:
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
