Directorate: Unscheduled Care and Medicine, Cancer and Clinical Services
Location: Altnagelvin Hospital Londonderry
Contract and hours: Permenent, Full Time (37.5hpw), A waiting list may also be established
Job summary
The Pharmacy Quality Manager will work predominantly in the Aseptic Manufacturing Unit and Quality Assurance service in Altnagelvin Hospital Pharmacy Department.
He/she will be responsible for ensuring there is a functioning Pharmaceutical Quality System (PQS) that meets the requirements of Good Manufacturing Practice as described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors, and that this is implemented, maintained and continually developed.
The Quality Manager will be responsible for working with all members of the Aseptic Manufacturing Unit and Quality Assurance teams to manage the Pharmaceutical Quality System that is in place to support the safe and effective operation of the Aseptic Manufacturing Unit.
He/she will also support the provision of assurance in other areas in Pharmacy as required by the Head of Pharmacy and Medicines Management.
Note. If the successful applicant is a registered pharmacist, 1 session per week working in a pharmacy area to support maintaining their continuing professional development can be facilitated. This may include working evenings, weekends and on-call
Main responsibilities
- Ensure the Pharmaceutical Quality System (PQS) is embedded in the day-to-day operation of the Aseptic Manufacturing Unit and Quality Assurance service as required under Good Manufacturing and Distribution Practice. This will include providing assurance that:
- The principles of risk management as described in ICHQ9 are used in decision- making
- Internal audit and associated actions to address deficiencies are completed
- Environmental monitoring is being carried out as required and trend analysis and investigation of environmental excursions is undertaken.
- Changes are controlled using the approved process.
- Training policies and competency assessments are complete for all staff.
- Outsourced activities are managed correctly.
- Complaints and product recalls are dealt with correctly.
- The documentation control system is being used correctly.
- Validation of computerised systems has been undertaken.
- Management of the assessment, safety, storage and supply of unlicensed medicines is in line with regulatory requirements and policies.
- Collation, reporting and investigation of errors and corrective and preventative actions (CAPA) are correct.
- COSHH assessments are undertaken for products used within aseptic services.
- Managing of the risks associated with new intravenous drugs (NPSA 20 Promoting the Safer Use of Injectable Medicines alert).
- Systems are in place to validate the cold storage within Pharmacy and for delivery using Trust transport- temperature mapping of pharmacy fridges and transport vehicles.
- Equipment, operators and processes have been validated according to the validation plan
- Demonstrate and apply expert knowledge and understanding of the principles and guidelines of Good Manufacturing and Distribution Practice (GMP and GDP), Good Clinical Practice (GCP) and the quality assurance of Aseptic Preparation Services.
- Maintain comprehensive standard operating procedures (SOPs) relevant to PQS that are valid, version- controlled, read, understood and followed, and provide assurance that Aseptic Manufacturing Unit SOPs are similarly managed.
- Assist the Pharmacy Aseptic Manufacturing Unit and the Quality Assurance service to meet the regulatory standards described in Rules and Guidance for Pharmaceutical Manufacturers and Distributors and in Annex 1 of The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use- Manufacture of Sterile Medicinal Products
- Responsible for providing reports, policy documents and advice relating to the management, development and monitoring of the quality of pharmacy aseptic services to the Principal Pharmacists in Aseptic Services and Quality Assurance and the Head of Pharmacy and Medicines Management.
- Ensure follow -up on external inspections and verify the completion of corrective action as required by the reports of the assessors...
For more details please see the full job description in the Additional Information section below
