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EMEA Sterility Assurance & Microbiology Manager, Mayo



Mayo, Ireland 

Job Category:

Biotech/Pharma, Science

EU work permit required:


Job Reference:


Job Views:




Expiry Date:


Job Description:

We are seeking applications for an experienced EMEA Sterility Assurance & Microbiology Manager to join our client. They will be the representative for all EMEA plants supporting the manufacture of Drug Product Solutions, Medical Devices, Bio-surgery products.

Why you should apply:

  • This is a fantastic opportunity to join a diverse, high-performing team that are engaged and innovative, and whose mission it is to save and sustain lives. Their innovative products and therapies can be found throughout hospitals and clinics as well as patients’ homes internationally.

What you will be doing:

  • 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 plant’s sterility assurance data through scheduled meetings with each plants FSA representative
  • Audit readiness – Using an 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:
  • Parametric Release
  • VIP/ Cost of Quality/ Laboratory efficiency / EMS – Identifying waste, increase laboratory efficiency and driving out non-value-added costs each plant’s 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.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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