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Band 6 Gmp Documentation

4 months ago

London, United Kingdom Royal Free London NHS Foundation Trust Full time

We are looking for a motivated individual with excellent communication, interpersonal and organisational skills who is dedicated to working as part of the team.

**Key duties of the role include**:
To assist in the maintenance and development of the Quality Management Systems across the Quality and Production departments, including but not limited to writing, reviewing and updating department procedures and policies and maintaining and developing the department’s documentation systems.

To act as a QA/QC Officer responsible for the approval or rejection of raw materials, intermediates, hospital-manufactured finished products, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records on the quality system and generation of Certificates of Conformity and Certificates of Analysis for external clients.

You will also contribute to the operations of the departments Pharmaceutical Quality System and assist with the provision of expert advice on all Quality matters that support the wider Pharmacy department.

Management and maintenance of a comprehensive documentation control system across RFH Technical Services.

Leading the implementation of eQMS for effective document control and quality management.

Assisting in transferring documents from the current filing system to the eQMS electronic Quality Management System.

Management of the review and approval process for all GMP documents.

Supporting the QA team in delivering high-quality services in accordance with the Medicines Act and Trust licenses.

Assisting in developing the QA service and provide expert advice on QA matters, with emphasis on Quality Control activity.

Ensuring GMP activities align with regulatory and legal requirements and comply with current GMP, company SOPs, and Health and Safety policies/SOPs.

Collaborating with other staff responsible for the environmental monitoring program.

Undertaking additional duties as required by the Head of Quality.

Our trust has around 10,000 staff serving 1.6 million patients. It comprises Barnet, Chase Farm and Royal Free Hospitals and more than 30 services in the community. Our mission is to deliver world class care and expertise in our clinical services, underpinned by world class teaching and research.

The Trust takes pride as one of the major specialist centres for infectious diseases, liver and renal transplants, breast and plastic surgery, myeloma, and neuroendocrine tumours. Working in one of the main speciality centres brings exciting opportunities to see a range of patients at different levels of complexities. Everyone is welcome at Royal Free London NHS Foundation Trust. We're proud of our diversity and we continue to undertake new initiatives to advance equality for LGBT+, BME, gender equality, staff carers and people with disabilities and lived experiences to promote good relations and understanding between our staff.

The Pharmacy department is a friendly, progressive, and expanding unit dedicated to providing the highest standards of pharmaceutical care and service in this internationally renowned teaching hospital. Quality improvement and cost-effective, safe use of medicines is at the forefront of everything we do.

**The responsibilities include**:
**Quality Management and Documentation Control**:
Manage and maintain a comprehensive documentation control system across RFH Technical Services.

Lead the implementation of eQMS for effective document control and quality management.

Assist in transferring documents from the current filing system to the eQMS electronic Quality Management System.

Oversee the day-to-day operation of eQMS.

Utilize eQMS for maintaining version control of all GMP documents.

Manage the review and approval process for all GMP documents.

Drive the development and review of new and updated documents.

Provide reports to Unit Managers on GMP documentation status, escalating concerns to the QA Specialist and the Head of Quality.

**Quality Assurance**:
Be an integral part of the Quality Assurance team, fulfilling QA responsibilities as needed.

Support the QA team in delivering high-quality services in accordance with the Medicines Act and Trust licenses.

Assist in developing the QA service and provide expert advice on QA matters, with emphasis on Quality Control activity.

Contribute to drug defect investigations, drug recalls, and investigation of patient complaints regarding Trust-manufactured products.

Undertake validation reviews and stay updated on the latest QA guidelines.

Ensure GMP activities align with regulatory and legal requirements and comply with current GMP, company SOPs, and Health and Safety policies/SOPs.

Utilize the deviation reporting system and change control system, analyzing and trending data.

Conduct internal audits of the Quality Control department and documentation control systems.

Collaborate with other staff responsible for the environmental monitoring program.

**Quality