Microbiology Technical Lead

3 weeks ago

Dublin, Dublin City, Ireland AstraZeneca GmbH Full time

This is what you will do:

The QC Microbiology Technical Lead is responsible for technical and quality oversight for activities within the QC Microbiology department. The Technical Lead will provide technical support with regard to method verification, Environmental Monitoring, Utilities and all other lab-based activities.

You will be responsible for:

  • Driving the validation/qualification of Microbiology test methods and test systems in support of in-process and commercial release testing
  • Author/ review and approval of laboratory validation protocols /reports as required and annual trend summary reports
  • Perform review of regulatory submissions
  • Responsible for the introduction of automation and rapid techniques within microbiology and the implementation of analytical changes
  • Performing technical review and approval of applicable BDS Utility validation protocols and reports
  • Manage Change Control process and drive implementation of related tasks.
  • Supporting the sterility assurance program for the facility to implement and maintain a robust aseptic processing and monitoring program
  • Providing SME support to the Manufacturing, Utilities and Projects teams (inclusive of NPI projects for commercial product and new builds) which the company undertakes through project participation and QC readiness
  • Representing QC at product and technical team meetings and lead/drive all associated support activities
  • Supporting management in continual enhancement of the QC strategic plan
  • Drive process efficiencies and develop CI capability, using CI tools to drive and support improvements within QC with a particular focus on new technologies

You will need to have:

  • B.Sc. degree in biological /chemical sciences, business, or other related technical degree or equivalent experience in regulated industry
  • Preferable 5-8 years' microbiological experience in quality control / cGMP Quality environment in a biotech, pharmaceutical or bio-pharmaceutical manufacturing environment
  • A high degree of technical competency in Microbiology methods, sterility assurance and aseptic filling
  • Demonstrated ability to successfully collaborate, influence and lead in a matrix organization
  • Excellent communication and interpersonal skills
  • Proven record in demonstrating agility
  • Experience of involvement in technical issue resolution, in a multidisciplinary environment.

We would prefer for you to have:

  • Experience of Trackwise and documentation systems.
  • Project management skills.
  • High level of proficiency in MS Office software including: Word, Excel, Outlook, Visio, and PowerPoint.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.


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