Job Summary
Senior Aseptic Quality Assurance Officer operating at Band 7. The post holder is responsible for overseeing and managing Good Manufacturing Practice (GMP) activities within Pharmacy, ensuring adherence to legislation, national guidance, and local policies. They will lead the implementation, development, and ongoing maintenance of the Pharmaceutical Quality System (PQS), monitor its effectiveness across aseptic and cancer services, and provide expert QA input into the review of aseptic products and processes to support continuous quality improvement.
Main Duties
* 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 (RCA), 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 offers 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 be supported to develop towards and apply for postgraduate courses such as the PTQA in the future. We are looking for motivated, forward‑thinking individuals who are keen to make a difference, drive quality improvement, and contribute to a patient‑centred service. In return, you will join a collaborative organisation that values its staff, supports career progression, and encourages continuous learning.
Qualifications
* 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.
* Evidence of ongoing CPD.
Desirable Qualifications
* 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
* 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
* 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.
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