NWSSP Pharmacy Division is recruiting to the position of Head of Production. The successful candidate will demonstrate extensive GMP knowledge and experience gained through production or quality assurance roles.
You will be managerially accountable for the staff, service and resources relating to production operational activity for the existing production unit ensuring that it meets Good Manufacturing Practice (GMP), Good Clinical Practice (GCP) and Good Distribution Practice (GDP) requirements, Health and Safety at Work, Control of Substances Hazardous to Health (COSHH), The Human Medicines Regulations and any other relevant statutory requirements, to deliver a timely, high quality and patient-focused service.
We are currently in the process of developing a radiopharmacy service with a new build unit based at IP5 adjacent to the current production unit. It is our intention to apply for a variation to our current specials licence to include the operation of this new state of the art facility for which the postholder will be responsible. The postholder will have a key role in developing this service and preparing the unit for MHRA licensing.
The post holder will be responsible at an operational level for holding the licenses for the unit, which may include:
1. Manufacturer’s License (Specials) (MS)
2. Manufacturer’s License (Investigational Medicinal Products) (MIA IMP)
3. Wholesale Dealing Authorisation (WDA)
4. Controlled Drugs License (Misuse of Drugs Act 1971 and Misuse of Drugs regulations (MDR) 2001 governed by the Home Office
In collaboration with the Head of Quality, the post holder will be responsible for maintaining formal contact with the MHRA inspectors and auditors and putting in place effective corrective and preventative actions (CAPA) in response to their inspection process.
The ability to speak Welsh is desirable for this post; English and/or Welsh speakers are equally welcome to apply.
At NHS Wales Shared Services Partnership we expect everyone to embrace our values of Listening and Learning, Working Together, Taking Responsibility and Innovating.
Our organisation encourages an agile working approach and we pride ourselves on being a learning organisation motivated by continuous improvement.
We are committed to creating an inclusive workplace that values equality, diversity and inclusion, focussing on the wellbeing and belonging of our people.
Excellent customer service is something we strive for, for both our internal and external customers.
Offering a comprehensive benefits package, there is something for everyone. To find out more about working for us, the benefits we offer and guidance on the application process please visit our website.
NWSSP work in an agile way where possible, all posts will have a contractual base but as part of agile ways of working that may mean working from home and other locations. We also look at how we balance flexibility with community, and how to manage opportunities to learn from each other.
For further details / informal visits contact:
Name: Laura-Jayne Keating
Job title: Deputy Director Pharmacy Services, NWSSP
Email address: laura-jayne.keating@wales.nhs.uk
Telephone number: 07879452213
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