About this role
Job summary
Join our Pharmacy Technical and Cancer Services Team and play a key role in ensuring the safe manufacture of medicines for patients across West Hertfordshire Teaching Hospitals NHS Trust.
We are looking for a motivated and quality focused Quality Assurance Specialist with a strong understanding of GMP to support the maintenance of our quality systems, MHRA Manufacturer's Specials (MS) Licence, and regulatory compliance.
Working closely with the Head of Quality and Quality Systems Manager, you will contribute to the development of high-quality Quality Assurance service through document control, equipment and facility compliance, drug recall coordination, and the continuous improvement of our Quality Management System, helping to maintain the highest standards of product quality and patient safety.
This is a full-time, permanent position Full details will be discussed at interview.
Main duties of the job
You will support the day-to-day operation of Quality Assurance, working collaboratively with Pharmacy Technical Services team to ensure compliance with GMP and MHRA requirements.
Your responsibilities will include reviewing and approving GMP documentation, coordinating equipment maintenance and calibration programmes, supporting manufacturing and quality investigations, managing drug recalls and safety alerts, maintaining quality records, and contributing to the continual improvement of the Quality Management System.
You will also provide expert quality advice to pharmacy staff, support regulatory inspections and audits, and help drive the ongoing development of safe, effective and patient-centred Pharmacy Technical Services.
You will work closely with Pharmacy Technical Services, Quality Control, multidisciplinary teams and external contractors to deliver an innovative, high quality service.
You will also contribute to education, training and service improvement initiatives while supporting the strategic development of the service.
About us With a new hospital planned for Watford, work underway to update theatres at St Albans City Hospital and plans for a neighbourhood healthcare centre in Hemel Hempstead, this is an exciting time to join us. We are building on the success of our award-winning virtual hospital and re-imagining models of care, working closely with partners and making the most of advances in digital healthcare. Staff wellbeing and development are a priority, as is the role of innovation in improving clinical care, outcomes and patient experience. Our vision is Excellent patient care, together and our values are to be empowered, compassionate, professional and inclusive. They capture an important balance across what we must all do as individuals and to support others. We offer a variety of flexible working options as we recognise the importance of a good work life balance.www.westhertshospitals.nhs.uk/flexibleworking If you have a disability or long-term health condition and require support or guidance please [email protected] If you are a Service Leaver, Veteran, Military Reserve, Cadet Force Adult Volunteer, or partner/spouse of those serving please tick "Member of the Armed Forces Community" on the application form. We reserve the right to close this advert early due to the volume of applicants. Please apply as soon as possible to avoid disappointment.If you do not hear back within 3 weeks of your application, please assume you have been unsuccessful on this occasion.
Job description Job responsibilities
This is a full-time permanent role, based at Watford General Hospital. Core working days are Monday to Friday, typically between 08:00 am and 16:30 pm, with participation on weekends, if required, in accordance with departmental requirements.
Please refer to the attached job description and person specification for a full list of duties and details about the role.
Person Specification
Education and qualifications: Essential
Degree in life sciences or equivalent. Registered with the Science Council, RSB, RSC or other relevant professional body.
Desirable
Evidence of further post qualification training in Technical Services / Quality Assurance. Up to date CPD portfolio.
Knowledge: Essential
Demonstrated understanding of the principles of GMP and QA in Aseptics/Production manufacturing environment. Demonstrated understanding of Pharmaceutical Quality Systems. Knowledge of Audit and validation (Annex 11 and Annex 15). Demonstrated understanding of the importance of hygiene standards in the preparation of medicines. Computer and IT competent. COSHH Regulations and Health and Safety at Work Act. Need for confidentiality.
Desirable
Relevant ISO standards. Electronic temperature monitoring systems (Kelsius). BD Cato aseptic workflow system. Annex 1 requirements.
Experience: Essential
Proven experience of working in Quality Assurance. Proven experience of working in a GMP / GLP environment of at least 5 years. Eligible as a Releasing Officer to release MS Specials products. Previous experience of physical and microbiological Environmental Monitoring. Proven experience of delivering training.
Desirable
Writing reports. Staff supervision, training and performance appraisal experience. Experience of implementing change. Developing training packages. Advanced use of e-mail, internet, MS Windows, MS Word, MS Excel, MS PowerPoint.
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 West Hertfordshire Teaching Hospitals NHS Trust
Address Watford General Hospital
Watford
WD18 0HB
United Kingdom
Employer's website http://www.westhertshospitals.nhs.uk (Opens in a new tab)