Product Quality Manager


REF: 4053

We are currently recruiting for a Product Quality Manager to provide leadership and QA management for the operation of batch review/release, non-conformance, change control and product risk assessment systems. To monitor performance of the systems in place and to provide leadership, communication and expertise to continuously improve QA compliance across the organisation.

We are ideally looking for: Someone to lead the Quality Assurance officer team to successfully deliver Quality products on time in full. This requires a highly motivated quality professional with drive and passion to inspire and deliver through the team reporting to them. You will need to demonstrate excellent communication skills and be experienced in the management of multidisciplinary teams delivering a variety of services & projects. Practical experience of Continuous Improvement and understanding of GMP Data Integrity requirements is essential.

Some key responsibilities will include: 

  • Lead, motivate and manage multidisciplinary teams with assigned responsibility for delivery and maintenance of services related to batch review, non-conformance Management, change control management, Quality Risk management and project delivery.
  • Ensure the batch review release system is effective in the timely release of in process and finished pharmaceutical products.
  • Where applicable, fulfil legal duties of the QP as defined in Annex 16 of the European Union Guide to GMP.
  • Ensure the non-conformance management system meets regulatory requirements and industry expectations.
  • Ensure the operation of the change control system supports the effective changes to improve systems and processes.
  • Ensure the Quality Risk Management system supports product impact assessments.
  • Provide Quality advice related to compliance and QA operational issues.
  • Review and approve QA and validation documents (e.g SOPs, protocols, reports).
  • Monitor the performance of the systems under area of responsibility using KPIs and report to management.
  • 1Develop and implement an ongoing Quality Improvement Plan related to the systems under area of responsibility.
  • Manage assigned budget within authority level.

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