Senior Aseptic Quality Assurance Officer
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The Band 7 Quality Assurance (QA) Officer plays a key role in ensuring the safe, compliant, and effective delivery of aseptic services within Pharmacy. The post holder is responsible for overseeing and managing Good Manufacturing Practice (GMP) activities, ensuring adherence to all relevant legislation, national guidance, and local policies.
They will lead the implementation, development, and ongoing maintenance of the Pharmaceutical Quality System (PQS), monitoring its effectiveness across aseptic and cancer services. The role provides expert QA input into the review of aseptic products and processes, supporting continuous quality improvement and maintaining high standards of patient safety.
The post holder will act as a senior QA Officer, supporting the delivery of a safe, efficient, and legally compliant aseptic service. Responsibilities include managing deviations, CAPAs, audits, risk assessments, and validation activities, as well as supporting staff training and governance processes.
Main duties of the job
Main Duties OverviewThe post holder will support the delivery of a high-quality, safe, and compliant aseptic pharmacy service by leading quality assurance activities, maintaining robust governance systems, and driving continuous improvement across all areas of practice. Please see full JD and PS for more information.
Person specification
Qualifications
Essential
- Relevant Science Degree or Post-graduate diploma level or equivalent level Experience and NVQ Level 3 in Pharmacy Services or Aseptic Pharmaceutical Science Manufacturing Technician level 3
- Professional Registration with the GPhC or Science Council for Science Manufacturing Technicians
Desirable
- Specialist higher diploma in technical services (e.g. PTQA or Scientific Training Programme) or working towards.
- Leadership and Management qualification or equivalent knowledge and experience
- Leeds University course in Aseptic Preparation and Dispensing of Medicines /Aston University course in Technical Pharmacy Training in Aseptic Processes or willing to complete.
Experience
Essential
- Experience of pharmacy manufacturing or other significant experience of working in a GxP environment
- Quality control and quality assurance experience including environmental monitoring.
- Experience of working within and maintaining a Pharmaceutical Quality Management System - Change Control, Deviation and Corrective and Preventive actions.
- Experience of validation, qualification and recommissioning
- Experience of participation in external audit and hosting external auditors.
- Experience of line managing personnel
- Experience of conducting quality -based investigations and root cause analysis
- Experience of HR policies and procedures.
Desirable
- Experience of chairing meetings
Skills
Essential
- Good organisational and time management skills.
- Able to work independently and show initiative within limits of own authority whilst following agreed procedures.
- Procedure and policy development
- Able to give feedback constructively and deal with issues sensitively.
- In depth and practical knowledge of the legislation and standards relating to GxP, ability to apply this knowledge to develop and maintain a Pharmaceutical Quality Management System.
Addtional Criteria
Essential
- Participate in the personal development and review systems of staff.
Values
Essential
- Ability to demonstrate the organisational values and behaviours
About the employer
Walsall Healthcare NHS Trust is an integrated Trust and the only provider of NHS acute care in Walsall, serving a population of 284,300, providing inpatient and outpatient services at the Manor Hospital as well as a wide range of services in the community. Walsall Manor houses the full range of district general hospital services under one roof. The £170 million development was completed in 2010 and the continued upgrading of existing areas ensures the Trust now has a state-of-the-art Critical Care Unit, Neonatal Unit, Obstetric Theatre, and Integrated Assessment Unit facilities.
A new Urgent Emergency Care Centre was opened in March 2023. The two-storey development has significantly improved emergency care facilities and capacity and has provided almost 5,000 square metres of additional clinical space.