Senior Aseptic Quality Assurance Officer
Title: Senior Aseptic Quality Assurance Officer – NHS AfC: Band 7. Location: Walsall Manor Hospital, Walsall. Salary: £49,387 – £56,515 per annum (pro‑rata). Hours: 37.5 per week, full‑time. Contract: Permanent. Job ref: 407‑WCCSS‑8011862. Closing 10/06/2026 23:59. Interview date 17/06/2026.
Job Overview
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 oversees and manages Good Manufacturing Practice (GMP) activities, ensuring adherence to all relevant legislation, national guidance, and local policies.
They 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.
Detailed Job Description and Main Responsibilities
- Lead and maintain the Pharmaceutical Quality System (PQS), ensuring compliance with GMP, legislation, and national guidance, and driving continuous quality improvement.
- Oversee investigations, root cause analysis, CAPA implementation, change control, deviations, complaints, recalls, validation, and quality trend reporting.
- Develop and manage the Quality Management Systems (QMS) and contribute to performance monitoring through KPIs.
- Provide expert QA advice to Aseptic Services, supporting high standards in product quality, process compliance, and patient safety.
- Lead and support deviation management processes, ensuring timely investigation, resolution, and effectiveness of corrective actions.
- Support environmental monitoring programmes, data analysis, trend identification, and implementation of improvement plans.
- Contribute to validation activities (URS, DQ, IQ, OQ, PQ), Validation Master Plans, and ongoing equipment and process qualification.
- Ensure compliance of materials, products, and specifications with GxP standards, including stability assessment and supplier agreements (SLAs/TAs).
- Support audits, self‑inspections, and governance activities, and deliver QA/GxP training to staff.
- Provide leadership, supervision, and line management, including staff development, recruitment, and performance management.
- Undertake ACT (accuracy checking and approval of pre‑filled chemotherapy).
- Contribute to operational service delivery, including aseptic preparation, dispensing, and cross‑functional duties as needed.
- Support safe use of medicines, risk management (including COSHH), and continuous improvement in patient care.
- Act as an authorised signatory for relevant financial and HR processes.
What We Offer
This role provides excellent opportunities for professional growth and development. You will be supported to expand your expertise in quality assurance and aseptic services, with potential opportunities for further progression. Where appropriate and subject to service needs and individual performance, there may be the opportunity to develop towards and apply for postgraduate courses such as the PTQA.
Person Specification
Qualifications
- Relevant Science Degree or Post‑graduate Diploma 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.
- Evidence of ongoing CPD.
- 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 willingness to complete.
Experience
- 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.
- Experience of chairing meetings.
Skills
- 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.
Additional Criteria
- Participate in the personal development and review systems of staff.
Values
- Ability to demonstrate the organisational values and behaviours.
Professional Registration Requirement
You must have appropriate UK professional registration.
Legal Requirements
This post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) and the Order 2020, and it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service.
Equality and Diversity
We would particularly welcome applications from people from a Black, Asian, and Minority Ethnic background and from people with a disability. These groups are currently under‑represented at senior level. We value diversity within our Trust and are working to achieve equality in our recruitment.
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