EMEA Sterility Assurance and Microbiology ManagerReq # JR - 002266 Location Castlebar, Connaught, Ireland Job Category Microbiology Date posted 01/30/2020
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Regional Sterility Assurance representative for all EMEA plants supporting the manufacture of Drug Product Solutions, Medical Devices, Bio-surgery products . P
Essential Duties and Responsibilities
- Provide direct quality oversight and Subject Matter Expert (SME) review at the plant level of sterility assurance, sterilization, microbiology, environmental monitoring and manufacturing area environmental control.
- Drive compliance with EU/FDA regulations, inspector’s expectations and execute the actions to implement Corporate Policy and Guidelines in each of the plants.
- Prepare the facilities for external/internal audits by proactively identifying and closing compliance gaps and also provide on-site support during inspections.
- Review and close external audit observations/findings and recommendations.
- Provide investigation root cause analysis guidance and support product batch release assessments.
- Coaching / mentoring facility sterility assurance (FSA) representatives, growing talent and developing competency regionally.
- Environmental Microbial - Applying corporate procedure GQP-08-09 Microbial Risk Control and Monitoring in the EMEA Region. Review and approve each plants Microbial control strategy and action plan documentation. Developing standardized sterility assurance compliance metrics and visual management. Ongoing review of each plants sterility assurance data through scheduled meetings with each plants FSA representative
- Audit readiness - Using a Audit Preparation and Audit Readiness checklist tool. Identifying and closing compliance gaps, driving improvement to reduce inspection observations and findings
- Coaching and mentoring - Using a Competency/Skills Matrix tool to assess microbiology / sterility assurance at each of the plants. Identify gaps in knowledge and areas for improvement. Provide the direct training and technical support. Share knowledge and best practice between facilities. Organise inter- plant assessments and site visits.
- Parametric Release - Submission and support of Regulatory Variations:
- VIP/ Cost of Quality/ Laboratory efficiency / EMS - Identifying waste, increase laboratory efficiency and driving out non-value added costs each plants microbiology/sterility assurance processes in line with core business priorities. Providing technical expertise and reviewing plant VIP with regards to compliance and assess the potential risks of implementation.
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