Head of Pharmaceutical Quality Assurance

Join Our Team as the Head of Pharmaceutical Quality Assurance!

An exciting opportunity has arisen for a senior pharmaceutical quality professional to be the named Quality Controller on the MHRA Manufacturer Specials (MS) License for the Pharmacy Aseptic Service at the Royal Surrey NHS Foundation Trust. We are embarking on an ambitious project to design a state-of-the-art modular aseptic manufacturing facility on our site, aimed at meeting the diverse needs of our patients. This cutting-edge facility will enable us to produce a range of ready-to-administer products, including cytotoxic medicines, monoclonal antibodies, and Investigational Medicinal Products (IMPs) for end users at RSFT.

If you are passionate about playing a vital and senior role in the design and delivery of safe, high-quality, and compassionate pharmacy services, this could be the perfect role for you. The position is advertised as an 8b to 8c development opportunity role.

Interviews are planned for week commencing 6 January 2025 and will be in person only.

Main duties of the job

In this pivotal role, you will manage all aspects of the Pharmaceutical Quality Management System (PQMS) that supports our MHRA-licensed Pharmacy Aseptic Service. As the named 'Quality Controller' on the MHRA Manufacturer 'Specials' (MS) Licence, you will be responsible for the release of products and play a critical role in the design and validation of our new facility.

You will collaborate closely with the Chief Pharmacist, Trust Executives, and the Pharmacy senior leadership team to ensure a quality-assured approach within the Aseptic Department, ensuring compliance with all regulatory requirements and adherence to GMP, GCP, and GDP standards. As the leader of the Pharmacy Aseptics Quality Team, you will work hand-in-hand with the Head of Production to provide strong and supportive leadership within the unit, fostering the development of the next generation of Pharmaceutical Quality professionals.

Additionally, you will be instrumental in shaping our Trust's role within the regional Aseptics strategy, collaborating with the regional Aseptics group to achieve the goals of the national Aseptics strategy. This includes forging strong links with other organisations in the South, including University Hospital Southampton and Frimley Health, and to align with the hub and spoke model.

About us

Royal Surrey is a compassionate and collaborative acute and community Trust. Recognising that our 5000 colleagues are our greatest strength, we offer a comprehensive health and wellbeing program along with a commitment to developing and advancing your career. Our diverse and welcoming Royal Surrey family will ensure you that you feel valued from your initial interview through your entire tenure.

We are clinically led and provide joined up care by bridging the gap between hospital and community services alongside regional specialist cancer care. Our main acute hospital site is in Guildford with community hospital sites at Milford, Haslemere and Cranleigh. We provide adult community health services in homes across Guildford and Waverley.

The Care Quality Commission (CQC) have given us an overall rating of Outstanding.

Royal Surrey has a strong reputation and history to build on. We are proud of our achievements and we are investing in our colleagues through our commitment to supporting professional development as well as investing more than £45 million in our physical environment and new equipment in the next few years. There has never been a better time to join us.

Although it isn't the Trust's normal practice, adverts may close early, so you are encouraged to submit an application as soon as possible.

Job description

Job responsibilities

Responsible for establishing and managing all aspects of the Pharmaceutical Quality Management System (PQMS) that supports the MHRA licensed Pharmacy Aseptic Service. The department manufactures a wide range of ready to administer products including cytotoxic medicines, monoclonal antibodies and Investigational Medicinal Products (IMPs) for end users at RSCH and external customers in order to minimise health and safety risks, infection risks and medication errors.

Be named Quality Controller on the MHRA Manufacturer Specials (MS) Licence, responsible for release of products. Management and Implementation of the Pharmaceutical Quality Management System. Work with the Chief Pharmacist and Pharmacy Section Heads to influence and advise on a quality assured approach within the Pharmacy Department. Ensure compliance with all regulatory requirements and adherence to GMP, GCP and GDP standards.

Person Specification

Qualifications

Essential

1. MSc Pharmaceutical Technology and Quality Assurance.
2. Registration with the General Pharmaceutical Council or membership of equivalent professional body e.g. Royal Society of Biology or Royal Society of Chemistry.

Desirable

1. Pharmacy or relevant Science degree to Master's degree level.
2. Registered as a 'Qualified Person' or equivalent experience.
3. Further qualification in management.

Knowledge

Essential

1. Specialist knowledge in Oncology.
2. Specialist knowledge of Parenteral Nutrition.
3. Proven experience of good performance in previous jobs.
4. Extensive demonstrable experience in a senior QA role in pharmaceutical manufacturing, including experience in a licensed facility.
5. Experience in a QC Laboratory and a QA Department.
6. Experience of managing and motivating staff.
7. Experience of training and supervising staff.
8. Specialist knowledge of Quality Management.
9. Experience of managing and developing a Quality Service.
10. Demonstrated experience and ability to successfully supervise and undertake a range of technical projects.
11. Demonstrated expert technical knowledge covering Pharmaceutical QA and Production.
12. In depth knowledge and understanding of all aspects of Good Manufacturing Practice, Quality Assurance and Good Clinical Practice and ability to apply this knowledge to develop and deliver quality services.
13. Demonstrated knowledge of principles and practices of aseptics/parenterals e.g. formulation.
14. Demonstrated knowledge of Pharmaceutical Microbiology.
15. Previous experience in delivering training and education in a relevant field.
16. Experience of business planning and financial reporting.
17. Knowledge of current developments in Aseptic Services and Oncology Practice.
18. Evidence of Continuing Professional Development.
19. Sound knowledge of Inclusion (equality and diversity) issues.

Employer details

Employer name

Royal Surrey NHS Foundation Trust

Address

Royal Surrey Hospital

Guildford

GU2 7XX

Any attachments will be accessible after you click to apply.

384-JH-EMF17216-B8c