Job summary
- Main area
- Pharmacy
- Grade
- Band 7
- Contract
- Permanent
- Hours
- Full time
- Part time
- Flexible working
- Job ref
- 427-6441388
- Employer
- Royal United Hospitals Bath NHS Foundation Trust
- Employer type
- NHS
- Site
- Royal United Hospitals Bath NHS Trust
- Town
- Bath
- Salary
- £43,742 - £50,056 pro rata
- Salary period
- Yearly
- Closing
- 26/08/2024 23:59
Employer heading
![Royal United Hospitals Bath NHS Foundation Trust logo](https://static.trac.jobs/employer-logos/319.png)
Lead Aseptic Services Quality Assurance Specialist
Band 7
Job overview
This is an exciting opportunity for an individual, with a commitment to openness and learning, to be a part of our quality and governance team in our new S10 aseptics unit at Royal United Hospital Bath NHS Trust
As part of an expanding QA and Governance team, the post-holder will undertake quality assurance and quality control activities across the department, and support cross cover across QA functions.
The S10 Aseptics service in RUH is designed to deliver a wide range of cyotoxics and monoclonal antibody products. We also manufacture radiopharmaceuticals under a S10 license, presenting a huge learning opportunity for the successful candidate
As a senior QA specialist you will help ensure our service complies with all relevant regulations. You will support wider development of expertise and assist with the implementation of new technologies and the introduction of preparation and new products.
We are seeking a dynamic individual with experience of working in technical services. Experience of working in licensed unit is desirable but not essential.
We strongly encourage applications from colleagues from protected and minority backgrounds and are happy to consider applications for part time or flexible working.
Please note that the vacancy may close early if a suitable amount of applications are received before the closing date.
Main duties of the job
• Develop, maintain and co-ordinate all aspects of GMP within the aseptic services unit
• Play an active and influential role in improving processes and implementing change.
• Manage and direct the microbial and physical environmental monitoring and quality control programmes within the aseptics unit.
• To ensure root cause analysis is conducted on all out of specification results
• Manage and direct the internal audit programme within the aseptics unit
• Assist and participate in external audits of the aseptic unit.
• Following comprehensive training if required Act as a Radiation Protection Supervisor (RPS) within the S10 unit.
Working for our organisation
At the RUH we put people at the heart of what we do, working together as one team to make a difference for our patients, each other, and our community. No matter what your role is, we value everyone’s contribution in supporting the exceptional, person-centred care we pride ourselves on.
We are proud to be in the top 20 best hospitals to work for in the country.
We are committed to creating a compassionate and inclusive environment. This can be seen in our growing community of staff networks – celebrating successes and creating opportunities to listen and learn. We value our differences, champion kindness and civility, and truly believe that diversity makes us stronger.
A culture of learning, developing and innovating is the thread that runs throughout our whole organisation. We want to support you to thrive, taking your career to its full potential.
We value staff wellbeing, with a well-established programme of support. We believe in a holistic approach spanning all aspects of living a healthy life, including physical, emotional, spiritual and financial wellbeing. We’ve even got a pool!
We are committed to supporting you and hope you want to join our team. In the meantime, find out more about living and working the beautiful historic city of Bath, learn about our extensive package of staff benefits, and read about how we’re providing healthcare fit for the future with the landmark Dyson Cancer Centre and our passion for research.
Detailed job description and main responsibilities
Please find attached to the vacancy a detailed person specification and job description for further information about this role.
Person specification
Qualifications
Essential criteria
- Degree in Pharmaceutical Science, Pharmacy, Biotechnology or equivalent science degree/certificate or equivalent experience
- Diploma in Pharmaceutical Technology and Quality Assurance or equivalent qualification/experience.
- Accredited Product Approver or willing to work towards acquiring the accreditation.
Knowledge and Experience
Essential criteria
- Previous extensive GMP hospital experience or extensive experience in pharmaceutical industry.
- Previous demonstrable extensive experience in Pharmaceutical quality management systems
- Strong knowledge of GxP, Pharmaceutical Quality Assurance and all current legislations and regulations
- Strong knowledge of risk management, deviations, investigations and CAPAs
- Experience in conducting audits.
Applicant requirements
The postholder will have access to vulnerable people in the course of their normal duties and as such this post is subject to the Rehabilitation of Offenders Act 1974 (Exceptions) Order 1975 (Amendment) (England and Wales) Order 2020 and as such it will be necessary for a submission for Disclosure to be made to the Disclosure and Barring Service to check for any previous criminal convictions.
Documents to download
Further details / informal visits contact
- Name
- Fiona James
- Job title
- Pharmacy Governance Manager & MSO
- Email address
- [email protected]
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