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

• Perform microbiology testing, including sterility and total viable count (TVC) testing
• Undertake validation of microbiology testing methods and procedures
• Review and approve results for release to customers for routine microbiological and chemical tests (e.g. culture plates, broth media and pH testing)

Environmental Monitoring and Equipment Validation

• Produce microbiological and physical environmental monitoring (EM) reports, including data trending and analysis
• Review and approve EM specifications
• Develop and maintain the annual EM testing schedule
• Review standard operating procedures (SOPs), manuals and master documents relating to EM, quality control and assurance, temperature monitoring and microbiological validation Contribute to validation activities, including User Requirement Specifications (URS), Design Qualification (DQ), Installation Qualification (IQ) and Operational Qualification (OQ) for monitoring equipment
• Support process development, validation activities and troubleshooting of equipment issues

Testing and Quality Control

• Perform sampling and analysis of raw materials, intermediates, finished products and packaging components
• Undertake pre-pack release checks and ensure compliance with approved sampling plans
• Record, interpret and report analytical results in accordance with procedures
• Conduct method validation testing and reporting
• Maintain reference samples in line with regulatory requirements
• Develop and apply trending tools to support quality systems and continuous improvement
• Complete and authorise equipment logs

Pharmaceutical Quality System (PQS) and Quality Management

• Support implementation of change management processes within the quality control environment
• Perform initial investigation and escalate out-of-specification (OOS) results as required
• Undertake OOS and out-of-trend (OOT) investigations
• Raise and manage corrective and preventative actions (CAPA) and change controls, including impact assessments
• Conduct investigations related to returns, complaints, and recalls, ensuring findings contribute to product quality review processes
• Contribute to annual PQS review reports

Supervision, Training and Development

• Deliver training, mentoring, and coaching to staff
• Assess competency for routine analytical and laboratory tasks
• Provide day-to-day oversight of laboratory and quality control functions
• Supervise QC and QA team members in daily operational activities
• Provide constructive feedback and support staff development
• Delegate tasks effectively across the team
• Promote and model good laboratory and cleanroom practices
• Witness cleanroom and equipment testing conducted by external suppliers
• Ensure safe and appropriate use of equipment by team members
• Monitor compliance with GMP, GLP, GDP, and COSHH standards, and challenge non-compliance where necessary

Stock and Inventory Management

• Support resolution of stock management issues relating to high-cost and high-risk medicines, including stock checks, receipt of goods, and falsified medicines assessment

Customer & Stakeholder Interaction

• Act as an initial point of contact for complaints, undertaking triage and escalation where required

Operational and Administrative Duties

• Verify documentation for accuracy and completeness
• Coordinate the secure destruction and retention of documentation in line with policies
• Escalate operational and personnel issues to the senior team as appropriate
• Ensure compliance with health and safety policies and procedures
• Manage and operate specialist systems and equipment (e.g. HPLC, LIMS, MALDI-ToF), maintaining a high level of technical proficiency
• Conduct COSHH assessments relevant to the work area
• Support colleagues with troubleshooting of technical and operational issues

Medical Gases Pipeline Systems (MGPS)

• Support the drafting and review of MGPS-related PQS documentation
• Perform calibration checks of MGPS testing equipment prior to use
• Undertake routine medical gas testing (e.g. compressors), including recording and approving results
• Plan and conduct non-routine medical gas testing activities
• Support ongoing calibration of MGPS equipment, including coordination with external providers

Leadership and Service Management

• Escalate operational and workforce issues to the management team as required

• 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
• Understanding of principles of pharmaceutical cleanroom testing (particularly for quality assurance roles)
• Understanding of pharmaceutical analytical and microbiological testing techniques (e.g. chromatography such as HPLC, mass spectrometry including MALDI-ToF), particularly for quality control roles
• Knowledge of Good Clinical Laboratory Practice (GCLP), especially for quality control functions

Desirable:

• Level 2 qualification in Leadership and Team Skills (or equivalent)
• Training or accreditation in education or supervision (e.g. Train the Trainer or Practice Supervisor training)

Considerations:

• This role may include supervisory responsibilities depending on the size, structure, and complexity of the organisation
• Post holders may act as expert users of specialist systems (e.g. HPLC, MALDI-ToF) within their area of practice

^*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)