Senior Pharmacy QA Officer

• To support the QA Manager in building, developing and monitoring the quality systems applicableto the pharmacy service with a particular focus on those relating to Manufacturing, WholesaleDealing and other registerable activity • To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc. • To undertake and support the preparation of SOPs. • To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment. • To participate in internal quality audits (Production Unit and Stores and distribution) and external audits as required. • To approve master worksheets, which relate to or might impinge upon licensable activities. • As a releasing officer, be responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records. • To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch • To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with ProductionManagement if results are outside of recommended guidelines. • To support and where indicated lead investigations into deviations in quality processes. • To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC. • Ensure appropriate escalation of all risks and outstanding corrective and preventative actions.Maintain relevant records, ensuring accurate data input into all computerised systems. • To support the operation of the QPulse document management system across the department. • Collect, interpret and present quality management data and statistics for use in monitoring the quality management system. • To support the development and application of the QMS to other areas of the pharmacy including the dispensary, and clinical pharmacy services working in association with Senior Pharmacy technicians and pharmacists. Job description Job responsibilities • To support the QA Manager in building, developing and monitoring the quality systems applicableto the pharmacy service with a particular focus on those relating to Manufacturing, WholesaleDealing and other registerable activity • To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects etc. • To undertake and support the preparation of SOPs. • To ensure satisfactory maintenance and monitoring of the aseptic manufacturing unit and equipment. • To participate in internal quality audits (Production Unit and Stores and distribution) and external audits as required. • To approve master worksheets, which relate to or might impinge upon licensable activities. • As a releasing officer, be responsible for the approval or rejection of raw materials, intermediates, hospital manufactured, commercial products and packaging materials and to keep appropriate records, including maintaining electronic records. • To evaluate Pharmacy manufacturing batch records, alongside Quality Control reports, prior to release or rejection of a batch • To be responsible for the review and reporting of all microbiological testing results provided by Quality Control including consultations and discussions of action plans with ProductionManagement if results are outside of recommended guidelines. • To support and where indicated lead investigations into deviations in quality processes. • To contribute to external inspection requirements relating to GMP and GDP eg MHRA , CQC , GPhC. • Ensure appropriate escalation of all risks and outstanding corrective and preventative actions.Maintain relevant records, ensuring accurate data input into all computerised systems. • To support the operation of the QPulse document management system across the department. • Collect, interpret and present quality management data and statistics for use in monitoring the quality management system. • To support the development and application of the QMS to other areas of the pharmacy including the dispensary, and clinical pharmacy services working in association with Senior Pharmacy technicians and pharmacists.