Job summary
- Main area
- Pharmacy
- Grade
- NHS AfC: Band 7
- Contract
- Permanent
- Hours
- Full time - 37.5 hours per week
- Job ref
- 432-HR669-24
- Employer
- East Suffolk and North Essex NHS Foundation Trust
- Employer type
- NHS
- Site
- Colchester Hospital
- Town
- Colchester
- Salary
- £43,742 - £50,056 per annum
- Salary period
- Yearly
- Closing
- 11/07/2024 23:59
Employer heading
Senior Quality Assurance/Quality Control Specialist (QA/QC)
NHS AfC: Band 7
We are one of the largest NHS organisation in England. Our scale provides exciting opportunities for development, innovation, research, education and training.
Talk to us about our range of flexible working opportunities, apprenticeships and staff benefits
Equality Diversity and Inclusion (EDI) is at the heart of all we do; and it forms part of the ESNEFT’s core activities. The Trust operates and relies on everyone treating each other with dignity and respect, to receive equitable and fair treatment in the implementation of Policies, Procedures and in its Practices, to foster positive work relationships, and finally to act with integrity as a professional within ESNEFT as well as a representative of the NHS as a whole. The EDI Agenda reflects the Trust values such as Optimistic, Appreciative and Kind. In line with the NHS Long Term Plan, People Plan, People Promise and a Model Employer intrinsic in the Equality Diversity and Inclusion Agenda, we consistently strive to improve, to take the learning into Action for a better ESNEFT.
If you are passionate about patient care and want to develop your skills and knowledge then we are keen to hear from you.
Job overview
Do you have extensive GMP hospital or industrial experience and are looking for your next step in your career at an acute hospital trust? Is so, we have the role for you.
Due to the expansion of our current product manufacturing service we have a new exciting role as a Senior Quality Assurance/Quality Control Specialist to join our Pharmacy Quality Assurance Department at East Suffolk and North Essex NHS Foundation. You will be based at Colchester Hospital, however you will be required to work across at Ipswich Hospital.
You will provide project management for our electronic pharmaceutical quality system. In additional you will have oversite of the QA/QC Officers and as you develop in the role you will then have line management of the team.
This is the ideal opportunity if you are looking to develop your knowledge and experience at a senior level within ESNEFT.
You will need good planning and organisational skills and must be able to demonstrate excellent communication.
Main duties of the job
- To support the Quality Management System and Operations Lead in setting up new products manufactured under MHRA MS Licence.
- To work collaboratively with the Production team in processing and closing out in a timely manner different QMS records such as Deviations, Corrective and Preventative actions (CAPAs) and Change Controls.
- To provide Quality Assurance support for all preparative and manufacturing activity taking place within the Technical Services department of the Pharmacy Service.
- To support the Quality Management System and Operations Lead in ensuring all aspects of Quality Assurance activity are carried out in according with Good Manufacturing Practice and in line with all requirements set out by the MHRA.
- To release manufactured products under the MHRA MS licence..
- To release unlicensed medicines as per the department procedures.
- To be the authorised releasing officer for batches as well as named patient manufactured products.
Working for our organisation
We are ESNEFT and we provide hospital and community health services to almost one million people across east Suffolk and north Essex. Our dedicated staff deliver care from acute hospitals in Colchester and Ipswich, community hospitals, surgeries, community clinics and in patients’ own homes.
We are one of the largest NHS organisations in England, employing more than 12,000 staff.
We pride ourselves on supporting our staff. We offer a wide range of training and development opportunities, as well as flexible working options.
Along with supporting you to achieve your career goals we offer a generous pension scheme, unsocial hours payments (where applicable), 27 days annual leave on commencement (pro rata) and access to a range of NHS discounts. Our Staff Health and Wellbeing programme offer a variety of services.
Our philosophy is that Time Matters to everyone. Across the Trust, we concentrate on improving the things we do and removing those which cause time delays for our staff and patients.
We are investing in our commitment to Time Matters with a partnership with leading electronic patient record (EPR) supplier Epic. This digital transformation will bring what’s widely regarded as the world’s best EPR system to ESNEFT, transforming life in hospital for staff and patients.
If you are passionate about patient care and want to develop your skills and knowledge, then we want to hear from you.
Find out about living and working here - www.youtube.com/watch?v=GkPu7HphU8A
Detailed job description and main responsibilities
For full details of the responsibilities and duties of this role please see the attached job description.
Person specification
Experience
Essential criteria
- Previous extensive GMP hospital experience (inclusive of Pharmacy Technical Services practice as required by MHRA guidance for specials manufactures for batch release) or extensive experience in pharmaceutical industry.
- Previous extensive experience in Pharmaceutical QMS
- Handling of high risk medicines
- Demonstrated experience of multi- disciplinary working
Desirable criteria
- Previous experience of sterile manufacturing
- Previous experience in Radiopharmaceuticals
Qualifications
Essential criteria
- Degree in Pharmaceutical Science, Pharmacy, Biotechnology or equivalent science degree/certificate
Desirable criteria
- Member of Royal Pharmaceutical Society, or Royal Society of Chemistry or Royal Society of Biology
- Postgraduate Diploma in Pharmaceutical Science or equivalent
- White belt certified or equivalent
Knowledge
Essential criteria
- Computer Literacy
- Intermediate/professional user of Microsoft 365
- Strong knowledge of cGMP/GLP, Pharmaceutical Quality Assurance and all current legislations and regulations
- Strong knowledge in Cytotoxic, CIVAS and Radiopharmaceutical manufactured products
- Knowledge of laboratory and production facilities SOPs and ability to revise and write new SOPs
- Strong knowledge of risk management, deviations, investigations and CAPAs
- Understand the principles of ALCOA plus
Desirable criteria
- Knowledge of legislation relating to the manufacture and distribution of human medicines
- Good clinical knowledge
Employer certification / accreditation badges
Documents to download
Further details / informal visits contact
- Name
- Mina Tawfik
- Job title
- Head of Quality Assurance
- Email address
- [email protected]
- Telephone number
- 075170911505
If you have problems applying, contact
- Address
-
Colchester General Hospital
- Telephone
- 07789651269
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