Senior Systems Quality Officer

Full Time Permanent

Global Pharmaceutical Manufacturer seeks an experienced Senior Quality Systems Officers.

About the role:

As a Senior Quality Systems Officer, you will be responsible for maintaining and improving the site PQS in line with company, corporate and international standards to support cGMP/GDP compliance and to meet business expectations.

You will be responsible for leading the continuous improvement of site quality systems, such as Quality Assurance Agreements, Annual Product Reviews, Planned Change, Deviations, CAPA, Complaints and Self-Inspection Schedule through monitoring the level of site wide compliance and effectiveness of the site PQS. The role requires the application of ICH Q9 (risk management), focussed initiatives, delivery of training, and maintenance of GMP operating procedures and documentation.

The role will include primary responsibility for the preparation of Quality Assurance Agreements, Self-Inspection Schedule and Annual Product Reviews together with any other reports and reviews necessary within the quality management system, which will require liaison with Clients and vendors to ensure all documentation is completed as defined by cGMP/GDP. You will provide support for other site projects, from a Quality Assurance perspective, by reviewing and approving where appropriate, project documentation including risk assessments, ensuring compliance with cGMP/GDP, company and other regulatory agency requirements.

About the ideal candidate:

You will have substantial experience within the pharmaceutical Quality Assurance environment, with strong experience of Self-Inspections, liaising with clients in relation to application and generation of Quality Assurance Agreements and completing Product Quality Reviews. You will have a thorough understanding of cGMP/GDP and its relationship with Quality Assurance Agreements, Self-Inspections and Annual Product Quality Reviews and other current best practices for the Pharmaceutical Quality System, and also the ability to work with concepts and practices often outside the original area of academic qualification.

You will ideally have a degree (or equivalent) in a scientific discipline, membership of a recognised professional body (e.g. RSC) would be an advantage. Other key skills are a keen eye for detail, an inquisitive, analytical mindset, with effective written and verbal communication skills and the ability to use computer software systems, including SAP or equivalent and Microsoft Packages (including


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