(AfC band 4 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. Morphology analysis of micro plates
2. ID (gram staining and microscopy, MALDI-ToF, speciation using API kit (or similar))
3. Carry out media fertility testing

Environmental Monitoring (EM) & Equipment Validation

1. Perform (routine or non-routine) cleanroom testing and validation
2. Perform (routine or non-routine) cleanroom equipment testing and validation
3. Ensure EM is carried out per programme
4. Provide training on EM, temperature monitoring/mapping, and micro validation
5. Prepare EM specifications
6. Approve EM test results and issued corrective actions for EM failures
7. Drafting/reviewing new/review of existing EM, QC/QA operational, temperature monitoring, or micro validation SOPs, Manuals, or Masters
8. Interpreting temperature monitoring data
9. Prepare and distribute temperature mapping report

Testing & Quality Control

1. Similar chemistry assays as previous role
2. Verification of equipment prior to use
3. Ensure equipment checks (pre-test) are carried out
4. QC checks of packaging and components
5. Prepare chemical testing reports (except HPLC)

PQS & Quality Management

1. Assist in OOS investigations
2. Participate in supporting tasks related to the maintenance of the PQS (or ePQS)/PQS processes, such as completion of documentation, supporting/gathering info for investigations.
3. Deviation reporting - initiation
4. Error reporting
5. Support implementation of change management within the cleanroom

Supervision, Training & Development

1. Providing training on EM, temperature monitoring/mapping, and micro validation
2. Providing internal and external training
3. Assist in supervision of junior staff activities and providing constructive feedback
4. Escalate personnel and operational issues to senior team
5. Effectively delegate tasks to others

Stock & Inventory Management

1. Raise and receiving (in system) purchase orders
2. Day-to-day stock management
3. Issue PST kits
4. Approve requests for clearance kits

Customer & Stakeholder Interaction

1. Deals with complainant - 1st point of contact
2. Identify external customers in receipt of defective medicine

Operational & Miscellaneous

1. Issue cleaning/transfer disinfection documentation
2. Checks on pre-packs
3. Aware of Health & Safety risks associated with line of work

Medical Gases Management (MGPS

• (No tasks provided for this category)

Leadership & Service Management

• (No tasks provided for this category)

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) (for the basic analytical lab skills with GMP understanding
• GCLP knowledge  particularly for QC roles
• Basic Leadership qualification or willing to complete as part of probation period – desirable