Walsall Healthcare NHS Trust

nhsjobs

Senior Aseptic Quality Assurance Officer @ Walsall Healthcare NHS Trust

Walsall, WS2 9PSOnsiteFull-timePosted 1 days ago

Opens on nhsjobs

About this role

Job summary

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.

About us

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.

Job description Job responsibilities

Key duties and main responsibilities include:

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 do 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.

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 Evidence of ongoing CPD.

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

Disclosure and Barring Service Check This post is subject to the Rehabilitation of Offenders Act (Exceptions Order) 1975 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service (formerly known as CRB) to check for any previous criminal convictions.

Certificate of Sponsorship Applications from job seekers who require current Skilled worker sponsorship to work in the UK are welcome and will be considered alongside all other applications. For further information visit the UK Visas and Immigration website (Opens in a new tab).

From 6 April 2017, skilled worker applicants, applying for entry clearance into the UK, have had to present a criminal record certificate from each country they have resided continuously or cumulatively for 12 months or more in the past 10 years. Adult dependants (over 18 years old) are also subject to this requirement. Guidance can be found here Criminal records checks for overseas applicants (Opens in a new tab).

UK Registration

Applicants must have current UK professional registration. For further information please see NHS Careers website (opens in a new window).

Employer details Employer name Walsall Healthcare NHS Trust

Address Walsall Manor Hospital

Moat Road

Walsall

WS2 9PS

United Kingdom

Employer's website https://walsallhealthcare.nhs.uk (Opens in a new tab)

Skills

NHS TrustHealthcareNHSPermanent

Ready to apply?

Install the ResuMinder extension and we'll auto-fill the application in seconds — no rewriting.

Get the extension →
Senior Aseptic Quality Assurance Officer at Walsall Healthcare NHS Trust | ResuMinder Jobs