An exceptional opportunity has arisen to provide Production leadership within the purpose built Medicines Manufacturing Centre (MMC). Based in Seaton Delaval, Northumberland, the MMC will produce sterile injectable medicinal products in line with MHRA Good Manufacturing Practice on behalf of the North East and North Cumbria Provider Collaborative. The post holder will act as deputy for the Head of Production and be responsible for the creation of production processes, training materials, SOPs and other quality documents.
Main duties of the job
1. To provide leadership on production related aspects within the MMC.
2. To meet clinical needs within the Integrated Care Services (ICS) for ready to use sterile injectable medicinal products.
3. To support the establishment of the MMC, as a leading Manufacturing Centre within the national NHS framework for aseptic transformation.
A successful candidate will be integral in establishing the production team for the delivery of anti-cancer and ready-to-administer sterile medicines for use in all 8 acute NHS Trusts in the NENC region.
Staff will be employed by Northumbria Healthcare Foundation NHS Trust until the formation of the Medicines Manufacturing Centre Legal Liability Partnership (LLP) is formed as a legal entity, after which TUPE regulations will apply.
Job responsibilities
1. Implement production policies which complies with Good Manufacturing Practice and current standards documents.
2. To lead in the creation of user requirement specifications for manufacturing equipment.
3. To select the contractors to provide the facility ensuring functional specification compliance with the user requirement specifications.
4. To manage the new product introduction process including process validation.
5. To assist in the development strategy to ensure a robust and fit for purpose manufacturing workforce.
6. To manage contractors and to lead on the commissioning and qualification of facilities and manufacturing equipment.
7. To manage the storage and distribution of manufactured medicines.
8. To lead on the ongoing maintenance and re-qualification of the MMC facilities.
Interview Information:
Candidates will be presented with a scenario before the interview, and allowed time to review and make notes which will be presented and discussed with the panel during interview.
Person Specification
Skills & Knowledge
Essential
* Master's degree in a scientific discipline or equivalent experience
* Registered Professional with the General Pharmaceutical Council (GPhC) or Academy for Healthcare Science (AHCS)
* Post-graduate qualification in Pharmaceutical Manufacturing or equivalent experience
Desirable
* Postgraduate diploma in Pharmaceutical Technology and Quality Assurance
* Management qualification
Experience and Knowledge
Essential
* Advanced theoretical and practical knowledge, gained through training, including pharmaceutical manufacturing, preparation, procurement and contracting, auditing and unlicensed medicines.
Employer details
Employer name
Northumbria Healthcare NHS Foundation Trust
Address
Seaton Delaval
Avenue Rd
Seaton Delaval
NE25 0QJ
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