Main Duties and Responsibilities:

The following apply either across all workstreams within smaller Section 10 units or to a specific workstream within larger Section 10 units or licensed services.^*1 

Microbial Testing and Analysis

• Authorise the release of media following successful completion of fertility testing
• Review and approve environmental monitoring (EM) results, including microbiological validation data

Environmental Monitoring and Equipment Validation

• Review and approve standard operating procedures (SOPs), manuals and master documents relating to EM, quality control and assurance, temperature monitoring and microbiological validation
• Review and approve EM specifications and requirements, including those arising following incidents
• Develop and implement corrective actions following EM failures
• Prepare and maintain the annual EM test schedule
• Distribute physical and microbiological EM reports to relevant service areas
• Act as an administrator for temperature monitoring systems
• Contribute to compliance with the Planned Preventative Maintenance (PPM) programme
• Coordinate validation activities across relevant services

Testing and Quality Control

• Perform and oversee analytical method validation testing
• Undertake chemical testing and ensure accurate interpretation of results
• Prepare, review and distribute chemical testing reports
• Approve test results, specifications, and reports relating to out-of-specification (OOS) and out-of-trend (OOT) findings
• Lead method validation activities for chemical testing, including approval of associated reports

Pharmaceutical Quality System (PQS) and Quality Management

• Draft, review, and approve standard operating procedures (SOPs), manuals, and master documentation within quality assurance systems
• Undertake risk assessment and investigation of non-conformances in accordance with established procedures
• Review and approve corrective and preventative actions (CAPA)
• Review and assess the effectiveness of change controls to ensure intended outcomes are achieved without introducing unintended risks
• Participate in quality management meetings and contribute to continuous improvement initiatives
• Contribute to the development of product quality review (PQR) reports
• Undertake initial assessment of potentially defective medicines, classifying defects as hazardous, major or minor
• Complete internal documentation relating to complaints and recall procedures
• Coordinate and support product recall activities where required
• Undertake targeted internal audits of processes to ensure compliance with quality standards
• Contribute to the development of annual PQS review reports

Training, Supervision and Development

• Conduct and document compliance monitoring activities (e.g. walk-round inspections and review of records)
• Supervise quality control, microbiology, chemistry, or quality assurance services, either across a team or within a defined specialist area
• Deliver internal and external training to staff and stakeholders
• Coordinate PQS-related workload activities
• Develop and manage staff rotas

Stock and Inventory Management

• Lead and troubleshoot stock management issues relating to high-cost and high-risk medicines, including stock control, receipt of goods, and falsified medicines assessment
• Draft and review service level agreements (SLAs) and technical agreements (TAs)

Customer & Stakeholder Interaction

• Assess complaints and ensure appropriate escalation or referral

Operational and Administrative Duties

• Act as a technical expert in the operation and troubleshooting of specialised systems and equipment (e.g. HPLC, LIMS, MALDI-ToF)
• Prioritise and schedule testing activities to meet service demands
• Review and approve MGPS-related documentation (SOPs, manuals, master documents)
• Conduct internal audits to ensure compliance with regulatory standards
• Coordinate and review COSHH assessments relevant to the work area
• Manage controlled documentation, ensuring appropriate issue, retrieval, storage and retention in line with policy

Medical Gases Pipeline Systems (MGPS)

• Act as a MGPS quality control specialist, undertaking and approving routine (e.g. compressors) and non-routine testing, including high-risk and permit-controlled activities
• Deliver training on MGPS processes and requirements
• Generate and approve medical gas testing reports

Leadership and Service Management

• Lead the development and maintenance of key performance indicators (KPIs), capacity tracking, and error reporting and trending
• Undertake line management responsibilities, including recruitment, selection, and management of performance issues

• Demonstrable Good Manufacturing Practice (GMP) knowledge and experience at Level 3 equivalent; or
• Level 3 qualification in Pharmacy or Science Manufacturing Technician (SMT); or
• Degree (BSc or MSc) in an applied science subject with relevant analytical laboratory skills and GMP understanding
• Experience in supervision of staff
• Understanding of the principles of pharmaceutical cleanroom testing, particularly for quality assurance roles
• Knowledge and experience of quality management systems within pharmaceutical technical services
• Understanding of analytical and microbiological testing techniques (e.g. HPLC, MALDI-ToF), particularly for quality control roles
• Knowledge of Good Clinical Laboratory Practice (GCLP), particularly for quality control functions

Desirable:

• Level 3 qualification in Leadership and Team Skills or equivalent
• Experience in line management of staff

Considerations:

• The scope and level of responsibility may vary depending on organisational size, structure and service complexity

^*1 Alignment with AfC job profiles may be supported through appropriate weighting of Factor 4 (Planning and Organisational Skills) and Factor 7 (Responsibilities for Policy and Service Development Implementation)