(AfC band 8a equivalent)

Main Duties/Responsibilities:

The following apply either to all workstreams if a small Section 10 unit (e.g. anti-cancer therapy + CIVAS) or to a specific workstream if a large Section 10 unit or licensed workstream (e.g. parenteral nutrition only)*1

Microbial Testing & Analysis

1. Manage micro monitoring system
2. Evaluate and approve micro monitoring reports
3. Establishes microbiological limits-alert and action

Environmental Monitoring (EM) & Equipment Validation

1. Approve temperature mapping plan
2. Evaluate EM trending and make recommendations
3. Review URS, DQ, IQ, OQ for equipment
4. Develop URS, DQ, IQ, OQ for facilities and complex equipment

Testing & Quality Control

1. Review and approve analytical method validation testing report
2. Approve specifications for consumables
3. Approve operator and process validations
4. Sign off/approval of reports for validations, testing, investigations, etc.

PQS & Quality Management

1. Review, approve and close out investigations, CAPA, change controls
2. Sign off non-conformance reports
3. Sign off approving CAPA and Deviations
4. Approve annual validation reports
5. PQS development and document approval
6. Approving internal audits
7. Approve COSHH policies and assurance reports
8. Prepare audit reports/action plans
9. Perform internal and supplier audits
10. Support external audits
11. Review and update existing Site Master File
12. Manages document control system {compliance with best practice, legislation}
13. Establishes document control system/policy
14. Manage change to programmes of testing and complex changes
15. Prepare a CCS
16. Be a formal contact for the MHRA inspectors and auditors and to put in place effective corrective and preventative actions (CAPA) in response to the inspection

Supervision, Training & Development

1. Oversee internal and external training and approve training SOPs, Manuals or Masters
2. Assess QC training programme effectiveness
3. Creates and approves Quality department training plans and documents
4. Deliver training and education as a subject matter expert (i.e. to peers)

Stock & Inventory Management

1. Oversee stock management activities/issues of high-cost and high-risk goods
2. Approve orders
3. Raise high-cost orders (equipment, PPM, etc.)
4. SLA/TA approval

Customer & Stakeholder Interaction

1. Inform and liaise with MHRA with regards supplied manufactured product identified as defective for information or action
2. Completes MHRA defective medicine reporting form
3. Investigates clinical implications if product already administered - impact assessment
4. Inform and liaise with MHRA with regards in-house manufactured product identified as defective for information or action
5. Medical Gas Committee

Operational & Miscellaneous

1. Carry out and write up whole system internal audits against a professional or regulatory standard
2. Designs SOP master template
3. Check, new or revised product specific worksheet template and label
4. Authorises or approves master record sheet
5. Designs and implements the complaints and recall procedures

Medical Gases Management (MGPS)

1. Governance of medical gases/policy
2. Oversee MGT procurement QA
3. Oversee Medical Gas Testing
4. Approve gas testing report
5. Oversee internal and external training on MGT

Leadership & Service Management

1. Accountable for the service delivery and operational management of a service/function/team
2. Assist in governance and strategic planning of the service(s)
3. Develop business cases for service improvements and expansion and budget management - reports, trending and authorised signatory
4. Accountable for monitoring and review of the Capacity and Contingency Plans
5. Contribute to review, set targets and amend KPI's
6. Responsible for service developments/improvement projects, including new equipment/technology
7. Conduct research activities within the department and support research activities within the organisation
8. HR duties of Line management of management staff, including recruitment & selection & performance issues
9. Integrate organisation-wide, regional and national work groups as a stakeholder

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
• Minimum of PTQA diploma or equivalent qualification / experience
• Leadership / project management qualification/certification
• Extensive experience in pharmacy QC/QA services
• Experience in supervision of staff
• Experience in line management
• Experience in service management
• Significant knowledge and experience in the principles and supporting development of quality management systems and pharmaceutical cleanroom testing  QA roles
• Significant knowledge and experience in the principles and supporting development/validation of pharmaceutical analytical/microbiological testing (i.e. chromatography (HPLC), MS (MALDI-TOF),etc)) - QC roles

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