(AfC band 5 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. Carry out sterility or TVC Testing
2. Perform sterility or TVC test validation
3. Approval of results for release to customer for simple microbiological and chemical samples (i.e. plates, broth, pH)

Environmental Monitoring (EM) & Equipment Validation

1. Create micro EM reports (including trending)
2. Create Physical EM reports (including trending)
3. Approve EM specifications
4. Prepare EM Annual Test Schedule
5. Review of EM, QC/QA operational, temperature monitoring or micro validation SOPs, Manuals or Masters
6. Contribute to URS, DQ, IQ, OQ for monitoring equipment
7. Not only following SOPs but also some development work (process validation?) and troubleshooting of equipment

Testing & Quality Control

1. Sampling and analysis of raw materials, intermediates, products, and packaging
2. Pre-pack release
3. Reporting of results
4. Adherence to approved sampling plans
5. Method validation testing and reporting
6. Retain reference sample
7. Develop trending tools for quality systems of work
8. Complete and sign off equipment logs

PQS & Quality Management

1. Support implementation of change management within the QC setting
2. Initial investigation and subsequent escalation, as required, of out of specification results
3. Perform OOS and OOT investigations
4. Raising CAPA and Change Controls (including impact assessment)
5. Carry out any investigations resulting from Returns, Complaints, and Recall, feeding results of investigation back into the Product Quality Review Process
6. Contribute to annual PQS review reports

Supervision, Training & Development

1. Delivery of training, mentoring, and coaching
2. Assessment of competence for simple analytical tasks
3. Delivery of training to entry/junior staff
4. Day-to-day oversight of laboratory / QC function
5. Day-to-day supervision of QC/QA team members
6. Provision of constructive feedback
7. Effectively delegate tasks to team
8. Model good laboratory behaviours and practices
9. Witnessing of cleanroom and equipment testing by external suppliers
10. Responsible for safe use of equipment by others
11. Monitor compliance of staff against GMP/GLP, GDP, COSHH standards and effectively challenge as needed

Stock & Inventory Management

1. Support troubleshooting of stock management activities/issues of high-cost and high-risk medicines, like stock checks, stock control, receipt of goods and falsified medicines assessment

Customer & Stakeholder Interaction

1. Deals with complainant - triage

Operational & Miscellaneous

1. Verification of documentation (for completion/issues)
2. Co-ordinate destruction of documents
3. Escalate operational and personnel issues to senior team
4. Ensure compliance with Health and safety policies or procedures
5. Management of specialist systems and related equipment (i.e. HPLC, LIMS, MALDI-TOF)
6. Working knowledge of all equipment
7. Perform COSHH assessments relevant to area of work
8. Support other staff members with troubleshooting of technical issues

Medical Gases Management (MGPS)

1. Support drafting / review of MGPS PQS documentation
2. Calibration of MGPS Testing equipment (pre-test)
3. Medical Gas Testing - Routine (Compressors) - perform/record results/approve
4. Medical Gas Testing - Non Routine - plan/perform/record results
5. Support calibrations of MGPS testing equipment, i.e. sending equipment for calibration

Leadership & Service Management

1. Escalate operational and personnel issues to management team

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
• Understanding the principles of 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 2 qualification in Leadership and Team Skills or equivalent - desirable
• Train the trainer/practice supervisor training/accreditation - desirable

Considerations:

• This role profile may entail supervision, depending on the size and setup of the organisation
• Expert users of particular systems (i.e. HPLC, potentially MALDI-TOF

*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