Overview
We are looking for a strategic and experienced leader to oversee the planning and coordination of a team involved in the aseptic manufacture of medicines. The role will involve working as a key member of the Senior Production Team to ensure compliance with the relevant regulations and statutory requirements.
The successful candidate will manage clinical governance and clean room operations, using data-driven insights to enhance processes, products, and equipment. They will play a pivotal role in developing new products and processes through Quality Risk Management (QRM) and Quality by Design (QBD) principles.
The role includes leading clinical training and professional development initiatives, with a focus on anticipating future service needs, particularly in workforce and training.
The ability to speak Welsh is desirable for this post; Welsh and/or English speakers are equally welcome to apply.
The role will involve leading on the strategic planning within a specialist production area to support the manufacture of aseptically prepared medicines under the MHRA Manufacturers Specials License, with a focus on delivering a high-quality, patient-centred service across Wales.
Key Responsibilities
* Lead a team of Production Supervisors and Operators engaged in the manufacture of aseptically prepared medicines, ensuring compliance with GMP, GCP, GDP, and other statutory regulations including Health and Safety, COSHH, IR(ME)R, and The Human Medicines Regulations.
* Line manage Senior Production Supervisors and support their team leadership responsibilities.
* Lead on the recruitment and selection processes, promoting inclusive access to the service.
* Identify and coordinate training needs for staff, trainees, and students in response to service changes.
* Manage the development of new products and work within an interdisciplinary team to design processes.
* Interpret and communicate complex technical and clinical information to support service standards and SOP development.
* Ensure regulatory compliance through risk management, validation, and quality system improvements.
* Manage procurement, stock control, and equipment maintenance, including high-risk material.
* Engage with multidisciplinary colleagues to propose and implement changes to policy relating to their specialist area.
* 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, focusing 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 https://nwssp.nhs.wales/working-for-us/
* 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.
* You will be able to find a full Job description and Person Specification attached within the supporting documents or please click Apply now to view in Trac
Key Responsibilities Include
* Leading the strategic planning and supervision of aseptic medicine production under the MHRA Specials license.
* Managing the Production Team and clean room operations to ensure compliance and efficiency.
* Overseeing training, mentoring, and development of staff, trainees, and students.
* Communicating complex technical and clinical information across multidisciplinary teams.
* Ensuring regulatory compliance through risk management, validation, and quality system improvements.
* Managing procurement, stock control, and equipment maintenance, including high-risk materials.
* Supporting audits, inspections, service improvement, and clinical research activities.
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