(AfC band 8c equivalent)
Main Duties / Responsibilities / Characteristics:
The following apply either to all workstreams if a small Section 10 unit (e.g. anti-cancer therapy + CIVAS) or to a specific workstream if a large Section 10 unit or licensed workstream (e.g. parenteral nutrition only)*1
Microbial Testing & Analysis
- (No tasks in this list fall under this category)
Environmental Monitoring (EM) & Equipment Validation
- Approval of Temp Mapping and Monitoring schedules
- Review URS, DQ, IQ, OQ for facilities
Testing & Quality Control
- If IMP, prepare QPIMP release certificate and certificate of analysis
- Product Release {or reject} under full Manufacturing Licence by QP/ QP IMP
PQS & Quality Management
- Responsible for the QA service, workforce development, design and build of new facilities
- Accountable for specification development and QA assessment (National contracting process)
- Oversee Defective medicines reporting/actions and supply chain issues
- Approve validation documentation
- Approve validation projects
- Approve audit reports/action plans
- Approve audit tools/programme
- Approve VMP and validation schedule
- Approve SMF/QM
- Oversee ULM management within the organisation
- Approves and oversees validation, documentation, protocol and strategy
- Oversee CCS and its effectiveness
Supervision, Training & Development
- Oversee internal and external training on MGT
Stock & Inventory Management
- Approve orders for high-cost equipment and manage budget
Customer & Stakeholder Interaction
- Oversee Defective medicines reporting/actions and supply chain issues
Operational & Miscellaneous
- Medical Gas Committee
- Governance of medical gases/policy
- Manage strategic direction of department/facility
Medical Gases Management (MGPS)
- Accountable to MGT procurement QA
- Accountable to Medical Gas Testing
- Approve gas testing reports
Leadership & Service Management
- Accountable for all systems of work concerning quality management
- Support/lead escalated HR functions (i.e. final hearings)
- Line management of managerial staff
- Approval of business cases
- Governance and strategic oversight of all services
- Oversee and approve business cases for service improvements and expansion
- Oversee the effectiveness of Capacity and Contingency Plans for Pharmacy Technical Services.
- Oversee of service developments/improvement projects, including new equipment/technology
- Oversee the management of targets and amend KPI's
- Support and oversee research activities within the department and support research activities within the organisation
- Oversee the development of the PQS (or ePQS)/PQS processes
- Integrate organisation-wide and regional work groups as a stakeholder
Requirements for applying to role:
- Well-founded GMP experience and understanding (Level 3 equivalent) or L3 qualification (Pharmacy or SMT) or Applied Science degree (BSc/MSc) (for the basic analytical lab skills with GMP understanding
- Minimum of PTQA MSc or equivalent qualification / experience
- Leadership / project management qualification/certification
- Extensive experience in pharmacy QC/QA services
- Extensive experience in supervision of staff & line management
- Significant experience in service management
- Significant experience in service improvement
- Extensive knowledge and experience in the principles and supporting development of quality management systems and pharmaceutical cleanroom testing
- Extensive knowledge and experience in the principles and supporting development/validation of pharmaceutical analytical/microbiological testing (i.e. chromatography (HPLC), MS (MALDI-TOF), etc))
