(AfC band 6 equivalent)

Main Duties/Responsibilities:

The following apply either to all workstreams if a small Section 10 unit or to a specific workstream if a large Section 10 unit or licensed*1

Microbial Testing & Analysis

1. Releasing media following fertility testing
2. Approve EM results, including micro validation

Environmental Monitoring (EM) & Equipment Validation

1. Approval of EM, QC/QA operational, temperature monitoring or micro validation SOPs, Manuals or Masters
2. Approve EM specifications
3. Approve EM requirements after an incident
4. Develop corrective actions following EM failure
5. Prepare EM Annual Test Schedule
6. Distribute PEM and micro EM reports to relevant service areas
7. Temperature monitoring system admin
8. Contribute to compliance of PPM programme
9. Coordinate validation activities

Testing & Quality Control

1. Perform analytical method validation testing
2. Perform chemical testing
3. Create and distribute chemical testing reports
4. Sign off test results / specs / OOS / OOT reports
5. Method validation for chemical testing, perform tests, approve reports

PQS & Quality Management

1. Drafting / reviewing new / review of existing QA SOPs, Manuals or Masters
2. Risk assessing and investigating nonconformances
3. Reviewing and approving CAPA
4. CC effectiveness
5. Drafting / reviewing new / review of existing QA SOPs, Manuals or Masters
6. Contribute to quality management meetings
7. Contribute to product review reports
8. Initial assessment of reported potentially defective medicine - hazardous, major or minor defect
9. Complete in-house documentation related to complaints and recall procedure
10. Coordinates recall procedure
11. Carry out targeted (internal) audit of simple processes
12. Develop annual PQS review reports

Supervision, Training & Development

1. Carry out and document compliance checks (walk rounds, review of logs etc)
2. Supervision of chemistry, micro QC, or QA service (small organisation) or of a team/lab (big organisation)
3. Delivering internal and external training
4. PQS system workload coordinator
5. Manage staff rotas

Stock & Inventory Management

1. Troubleshoot stock management activities/issues of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods and falsified medicines assessment
2. Write SLA/TAs

Customer & Stakeholder Interaction

1. Assess complaint and refer onwards

Operational & Miscellaneous

1. Troubleshooter and expert of specialised systems and related complex equipment (i.e. HPLC, LIMS, MALDI-TOF)
2. Prioritising and scheduling tests
3. Approve new / review of MGPS SOPs, Manuals or Masters
4. Conduct internal audits
5. Coordinate and review COSHH assessments relevant to area of work
6. Issues and retrieves controlled documents
7. Ensures systems for safe and secure storage of documentation for requisite period used

Medical Gases Management (MGPS)

1. Act as MGPS QC: Routine (Compressors) - perform/record/approve results & Non-Routine (high hazard permits) - plan/perform/record results
2. Medical Gas Testing - Non Routine - plan/carry out/record results/approve
3. Delivering internal and external training on MGPS
4. Generate gas testing report

Leadership & Service Management

1. Lead on the maintenance of KPIs, capacity tracking and management of errors/error trending
2. HR duties of Line management, including recruitment & selection & performance issues

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
• Experience in supervision of staff
• Understanding the principles of typical pharmaceutical cleanroom testing - QA roles
• 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
• Level 3 qualification in Leadership and Team Skills or equivalent – desirable
• Experience in line management - 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