(AfC band 8b equivalent)

Main Duties/Responsibilities:

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

1. Sterility testing - Design validation test method
2. Sterility testing - Design Strategy

Environmental Monitoring (EM) & Equipment Validation

1. Approve URS, DQ, IQ, OQ for equipment
2. Review URS, DQ, IQ, OQ for facilities

Testing & Quality Control

1. Approve programmes of testing (protocols, methods, frequency and limits)
2. Approve temperature mapping
3. Deputise for approval of method validation

PQS & Quality Management

1. Oversee and assess effectiveness of PQS processes? (i.e. CAPA, CC, Dev)
2. Perform QA evaluation of out-of-specification investigations (including re-test approval and close out)
3. Approve validation documentation
4. Approve validation non-conformances
5. Review and approve calibration certificates for equipment and consumables
6. Approve validation projects
7. Approve audit reports/action plans
8. Lead external/supplier audit
9. Develop audit tools/programme
10. Approve VMP
11. Approve SMF/QM
12. Manage audit programme
13. Review and approve CCS
14. Support the oversight the development of the PQS (or ePQS)/PQS processes, such as review and approval of data trends and critical documentation
15. Be a formal contact for the MHRA inspectors and auditors and oversee effective corrective and preventative actions (CAPA) in response to the inspection and complaints, errors and incidents within the services.

Supervision, Training & Development

1. Oversee internal and external training
2. Line management of senior staff

Stock & Inventory Management

1. QTA / SLA approval

2. Approve orders for high-cost equipment and support managing budget

Customer & Stakeholder Interaction

1. Implement and maintain a robust system to reduce the risk of falsified medicines entering the supply chain
2. Medical Gas Committee
3. Chair quality review meeting

Operational & Miscellaneous

1. Governance of medical gases/policy
2. Creating and maintaining the SOP master plan
3. Authorises or approves SOP master template
4. Final sign off of Validation Process outcome
5. Carry out and write up whole system audits against a professional or regulatory standard

Medical Gases Management (MGPS)

1. Oversee MGT procurement QA
2. Oversee Medical Gas Testing
3. Approve gas testing report
4. Oversee internal and external training on MGT

Leadership & Service Management

1. Support escalated HR functions (i.e. final hearings)
2. Accountable for the service delivery and management, governance and strategic planning of all QC/QA services
3. Maintain a safe and effective overall service, evaluating and prioritising services when constraints occur, and liaising and negotiating with internal and external stakeholders.
4. Review and internal approval of business cases for service improvements and expansion
5. Oversee monitoring and review of the Capacity and Contingency Plans
6. Oversee of service developments/improvement projects, including new equipment/technology
7. Review, set targets and amend KPI's
8. Lead research activities within the department and support research activities within the organisation
9. Integrate organisation-wide, regional and national 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
• Experience in service improvement
• Significant knowledge and experience in the principles and supporting development of quality management systems and pharmaceutical cleanroom testing
• Significant knowledge and experience in the principles and supporting development/validation of pharmaceutical analytical/microbiological testing (i.e. chromatography (HPLC), MS (MALDI-TOF), etc))

Considerations:

• Difficult to identify a distinction between profiles G and H. Partly this will depend on the scope and size of the department/organisation.

*1 Alignment of this profile with AfC job profile may be achieved by adjusting AfC Factor 4 (Planning and organisational skills) and Factor 7 (Responsibilities for policy and service development implementation) accordingly