Main Duties, Responsibilities and Characteristics:

The following apply either across all workstreams within smaller Section 10 units (e.g. combined anti-cancer therapy and CIVAS services) or to a specific workstream within larger Section 10 units or licensed services (e.g. parenteral nutrition only).^*1 

Microbial Testing and Analysis

• No specific tasks identified within this category at present

Environmental Monitoring and Equipment Validation

• Review and approve temperature monitoring, mapping programmes and schedules
• Provide strategic oversight of validation documentation for facilities, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ)

Testing and Quality Control

• Where applicable (e.g. Investigational Medicinal Products), prepare Qualified Person (QP) certification documentation including QP IMP release certificates and certificates of analysis
• Authorise or reject product release under a Manufacturing Licence, acting in the capacity of a QP where appropriate

Pharmaceutical Quality System (PQS) and Quality Management

• Hold overall responsibility for the quality assurance service, including workforce development and the design and commissioning of new facilities
• Provide strategic leadership for specification development and quality assurance assessment within national and organisational contracting processes
• Oversee the management and reporting of defective medicines, including associated actions and supply chain risk mitigation
• Approve validation documentation, validation programmes and associated projects
• Approve audit reports, audit programmes and associated action plans
• Approve key quality system documentation, including the Validation Master Plan (VMP), Site Master File (SMF) and Quality Manual (QM)
• Provide organisational oversight of unlicensed medicines (ULM) management processes
• Oversee the development, implementation and effectiveness of validation strategies, documentation and protocols
• Provide strategic oversight of the Contamination Control Strategy (CCS) and ensure its continued effectiveness
• Provide oversight of training and competency frameworks, including internal and external training related to specialised areas such as medical gases

Training, Supervision and Development

• Provide oversight of training and competency frameworks, including internal and external training related to specialised areas such as medical gases

Stock and Inventory Management

• Approve procurement of high-cost equipment and provide oversight of associated budget management

Customer and Stakeholder Interaction

• Provide strategic oversight of defective medicines reporting and associated risk management across the supply chain
• Act as a senior representative in governance forums and stakeholder groups

 Operational and Administrative Duties

• Provide governance oversight for medical gases policy and related systems
• Chair or contribute to relevant governance groups (e.g. Medical Gas Committee)
• Provide strategic leadership for departmental or facility direction and development

Medical Gases Pipeline Systems (MGPS)

• Hold accountability for procurement quality assurance relating to medical gas testing
• Provide oversight of medical gas testing programmes and approve associated reports

Leadership and Service Management

• Hold accountability for all quality management systems and associated governance frameworks across the service
• Lead or support complex workforce matters, including senior HR processes (e.g. formal hearings)
• Provide line management to senior and managerial staff
• Approve business cases for service development and expansion
• Provide governance and strategic oversight across all services within scope
• Oversee the effectiveness of capacity and contingency planning
• Lead service development and improvement initiatives, including implementation of new technologies and service models
• Oversee the setting, monitoring and refinement of key performance indicators (KPIs)
• Provide strategic oversight of research and innovation activities
• Lead the development and continuous improvement of the Pharmaceutical Quality System (PQS or ePQS)
• Represent the organisation at regional and national level as a senior stakeholder

Requirements for applying to role:

• Demonstrable Good Manufacturing Practice (GMP) knowledge and experience at Level 3 equivalent; or
• Level 3 qualification in Pharmacy or Science Manufacturing Technician (SMT); or
• Degree (BSc or MSc) in an applied science subject with relevant analytical laboratory and GMP knowledge
• MSc in Pharmacy Technical Quality Assurance (PTQA), or equivalent qualification or experience
• Extensive experience in pharmacy quality control and/or quality assurance services
• Extensive experience in staff supervision and senior line management
• Significant experience in service management and organisational leadership
• Significant experience in service improvement and transformation
• Extensive knowledge and experience in the development and governance of quality management systems and pharmaceutical cleanroom testing
• Extensive knowledge and experience in analytical and microbiological testing and validation methodologies (e.g. HPLC, MALDI-ToF), where applicable