(AfC band 7 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. Review environmental monitoring results
2. Review Quality Control testing results - microbial
3. Responds to out specification micro results and produces action plan (production action)

Environmental Monitoring (EM) & Equipment Validation

1. Develop temperature mapping plan
2. Approve EM Annual Test Schedule
3. Approve corrective actions following EM failure
4. Review and approve chemical testing reports
5. Design or approve physical monitoring programme including methods, frequency & limits
6. Review Quality Control testing results - chemical
7. Check equipment operation (e.g., steriliser cycle meets acceptance criteria)
8. Approve Annual Validation Schedule

Testing & Quality Control

1. Review and approve chemical testing reports
2. Review Quality Control testing results - chemical
3. Product Release (or reject) under Specials Licence by Designated QA Release Officer

PQS & Quality Management

1. Perform Design Qualification (DQ) against URS
2. Develop URS, DQ, IQ, OQ for equipment
3. Contribute to URS, DQ, IQ, OQ for facilities and complex equipment
4. Review and assess non-conformance reports, approval of minor risk ones
5. Reviewing and approving CAPA
6. Prepare annual validation and trending reports
7. Manage internal and external training and approve training SOPs, Manuals or Masters
8. Manage operator and process validations
9. Complex risk assessments and investigations
10. Develop specifications for consumables and starting materials
11. Responds to out specification micro results and produces action plan (production action)
12. Carry out internal audits
13. Support external audits

Supervision, Training & Development

1. Manage internal and external training and approve training SOPs, Manuals or Masters
2. Delivers training and assessment of competency for quality department

Stock & Inventory Management

1. Monitor stock management activities/issues of high-cost and high-risk goods
2. QTA / SLA review and development
3. Approval of orders

Customer & Stakeholder Interaction

1. Approve action plans in response to complaints

Operational & Miscellaneous

1. Generate gas testing report
2. Manage and oversee microbiological test schedules
3. Designs and approves micro monitoring protocols/programmes
4. Performs Design Qualification (DQ) against URS
5. Contribute to URS, DQ, IQ, OQ for equipment

Medical Gases Management (MGPS)

1. Medical Gas Testing - Non Routine - plan/perform/record results/approve
2. MGT procurement QA
3. Generate gas testing report
4. Approve new / review of existing MGT SOPs, Manuals or Masters
5. Manage servicing of MGT equipment/calibration (external)
6. Delivering internal and external training on MGT

Leadership & Service Management

1. Manage and contribute to the strategic planning of tasks within the service (small organisation) or team/function (big organisations)
2. Key member in service development/improvement projects, including new equipment/technology, and developing new products and processes using Quality Risk Management (QRM) and Quality by

Design (QBD) principles

1. Monitor and review of the Capacity and Contingency Plans
2. Integrate organisation-wide and regional work groups as a stakeholder
3. Support research activities within the department
4. Line management

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 certificate (foundations) or equivalent qualification / experience
• Experience in supervision of staff
• Significant experience in pharmacy QC/QA services
• Experience in supervision of staff
• Experience in line management
• Experience in supporting service management
• Significant knowledge and experience in the principles of quality management and typical pharmaceutical cleanroom testing  QA roles
• Understanding the principles of typical pharmaceutical analytical/microbiological testing (i.e. chromatography (HPLC), MS (MALDI-TOF), etc))  QC roles
• GCLP knowledge- particularly for QC roles
• Leadership / project management qualification/certification - desirable

Considerations:

*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