6 month contract with option to extend
Quality Assurance Manager Radiopharmaceuticals – External Manufacturing Department
External Manufacturing Organisation (EMO)
Purpose of the position:
The QA Manager – External Manufacturing will ensure that the highest standards of Quality Operations (QA & QC) are implemented and maintained at Contract Manufacturing Organisations (CMOs) and Contract Laboratories.
Main responsibilities and tasks:
Quality Assurance -
Deploy and maintain GxP Quality Management Systems with CMOs and Testing Laboratories to ensure compliance with regulations and inspection readiness at all times.
Deploy and maintain a Quality Auditing capability with use of CAPAs to identify and track required improvements.
Ensure that critical quality issues are reported to company management using the Global Quality alert process.
Review and sign-off of master production, process validation and cleaning validation documentations provided by CMOs.
Carry out the disposition of Finished Products, APIs, Raw Materials and Components when required.
Quality Strategy -
With the Director of Quality and Director of Relationship Management, develop a quality strategy aligned with the overall business strategy
Reduce and mitigate product risks
Develop opportunities for improvement
Risk Management -
Identify risks associated with products and systems
Appropriately remediate and mitigate risks associated with systems & products
Continuous Improvement -
Identify and implement opportunities to simplify EMO business processes including sampling, testing and data generation.
Support initiatives to meet or exceed Quality objectives. Contribute to continuous improvement planning and execution.
Contribute to the deployment of the Global Technical & Quality roadmap for External Manufacturing.
-Ideal: MSc in a Life Sciences discipline. 7 years' hands-on experience gained in both Quality Assurance and Quality Control departments with at least 3 years in a Supervisory position and radiopharmaceutical experience.
-Minimum: BSc or equivalent in a life sciences discipline, chemistry or biochemical engineering. 5 years' hands-on experience gained in both Quality Assurance and Quality Control departments and experience with radiopharmaceuticals.
Thorough knowledge of cGMP guidelines gained through practical experience of supporting cGMP manufacturing operations.
Extensive experience of Internal & External Quality auditing, CAPA management, deviation management & risk assessments. Preparation for FDA and EMA inspections.
Knowledge of biotech and aseptic manufacturing and processes, and product testing methods.
Familiarity with LIMS, EQMS (Trackwise), EDMS (Documentum) and EBR (Syncade) or equivalent Quality systems.