Lead Qualified Person
About the role
We have an exciting opportunity for a Lead Qualified Person to join us at Alliance Medical This is a full time role working 40 hours a week on a permanent basis.
We are ideally looking for an experienced Qualified Person, with management experience and responsbility for a Quality Management System. It is preferable that you have experience as a releasing QP within Radiopharmaceuticals/ steriles on a UK MHRA licence.
This role covers batch release of Radiopharmaceuticals for use in diagnostic PET scanning and contributing to the management of QMS.
In this role, you will ensure the Local and Global Quality System operates in accordance with Good Manufacturing Practice (GMP) and local procedures, working closely with the Head of Quality, QPs, and Site Management.
You will manage both permanent and contract Qualified Persons (QPs) across UK commercial manufacturing sites, reporting directly to the Head of Quality
. Your responsibilities include chairing the QP Forum meeting and performing duties as a Qualified Person as specified by various UK and EU regulations and directives.
You will review, certify, and release batches in a timely manner, ensuring compliance with GMP and Marketing/Clinical Trial Authorisations. Additionally, you will handle deviations, complaints, CAPAs, and OOS/OOT investigations, and review and approve Standard Operating Procedures and Forms.
You will play an active role in the withdrawal and validation process, reporting quality defects to the DMRC, and work with the Head of Quality to maintain and improve the Global Quality system.
Managing the QP team to meet project milestones, developing good working relationships with site staff, QPs, and the Inspectorate, and acting as a coach and mentor in Quality Assurance are also key aspects of your role.
You will attend site Quality Management Meetings, proactively address issues, and participate in MHRA inspections of the main site while supporting other sites as needed.
Please note that we will be interviewing throughout the duration of this advert. Therefore if you are interested in this role an early application is advised as we may close the advert prior to the advertised date.
Skills and experience
The ideal candidate for this role will have a strong background in pharmaceutical manufacturing, quality assurance, and regulatory compliance, and have excellent attention to detail and problem-solving skills.
Skills
Experienced in Microsoft Windows, Word, Excel and PowerPoint.
First class written and communication skills
Understanding of PrOFS.
Excellent interpersonal skills; personable.
Excellent organisation skills.
Good timekeeping.
Good attention to detail.
Good listening skills.
Self-motivated.
Able to work on own; proactive including both defining and executing tasks.
Leads by example.
Good regulatory knowledge (GMP, Safety)
Experience
Previous experience in QP certification of medicinal products.
Previous experience in a pharmaceutical manufacturing organisation, ideally with sterile products.
Previous experience ideally named Responsible Person (WDA) or responsible for (QPPV) Pharmacovigilance (desirable)
Minimum Qualification
Eligible to be nominated as a Qualified Person on the AMR Manufacturing Licences.
Member of one of the relevant Professional Bodies to permit QP eligibility.
Minimum of 10 years Quality Assurance Experience within a UK licensed Pharmaceutical Organisation
Minimum of 5 years management experience of Quality Teams ; Quality Assurance or Quality Control.
About us
Alliance Medical are Europe’s leading independent provider of imaging services.
We combine service excellence and innovative imaging technologies to improve patient care and support NHS and independent organisations with their ongoing imaging requirements. Our approach has delivered consistent company growth for more than 30 years.
We live by our company values to ensure the highest level of patient care:
Our Values
Leaders, managers, and supervisors have a particular responsibility to be role models in terms of how they demonstrate these values themselves and how they engage their teams to work in this way.
Collaboration:
We work together and in partnership for all our patients. We respect expertise and combine it to achieve more.
Excellence:
We never compromise. We strive to deliver the very best in everything we do to ensure the highest quality of care. We treat our patients and each other with compassion, dignity and respect.
Learning:
Knowledge and understanding comes from learning. At Alliance Medical we are committed to ensuring that each and every one of us keeps on learning and that we continuously look for improved ways of working.
Efficiency:
Efficiency in healthcare means more patients get better care. We constantly seek new ways to use the scarce resource of healthcare more intelligently so that more people can live longer, fuller lives.
Openness:
We act with transparency and honesty in everything we do, where staff are encouraged to speak up to ensure a safe and secure environment for our patients.