Senior Pharmacy QA Officer

Job overview

We are seeking an experienced and motivated Senior Pharmacy Quality Assurance Officer to join our Pharmacy Quality team. This is an exciting opportunity to play a key role in maintaining and developing a robust Quality Management System (QMS) within a pharmacy operation that holds a Wholesale Dealer's Licence (WDA(H)) and is subject to inspection by the Medicines and Healthcare products Regulatory Agency (MHRA).

The successful candidate will support the Chief Pharmacist, Responsible Person (RP), and Quality Assurance Manager in ensuring compliance with Good Distribution Practice (GDP), Good Manufacturing Practice (GMP) principles where applicable, Human Medicines Regulations, and all relevant quality and regulatory requirements governing the procurement, storage, distribution, and supply of medicinal products.

This role requires a highly organised individual with a strong quality mindset, excellent attention to detail, and the ability to influence quality standards across multidisciplinary teams.

If you have a passion to provide an excellent, patient focused pharmacy service within a busy but friendly department, we encourage you to apply.

Main duties of the job

Support the QA Manager in building, developing and monitoring the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing and Wholesale Dealing.

To review and approve quality documentation and systems including change management, GMP / GDP deviations, recalls, complaints, product defects.

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.

Ensure adherence to the PQS through appropriate training and motivation of Pharmacy staff.

Ensure continuing adherence to the requirements of PQS through regular internal inspections and report compliance via the Pharmacy Governance.

Detailed job description and main responsibilities

• To support the QA Manager in building, developing and monitoring the quality systems applicable to the pharmacy service with a particular focus on those relating to Manufacturing, Wholesale Dealing 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 Production Management 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.