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Sr. Project Manager/Project Manager, QA Microbiology

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 19/10/2018
  • Job reference: BBBH15562

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Responsible for planning, coordinating and facilitating microbial control activities required for the development and commercialisation of My client's drug candidates. This role will interact with all site functions that could impact on My client's microbial control program including Facilities, QC Microbiology, Manufacturing, Process Sciences, Engineering etc. and will provide ongoing support to evaluate and enhance the site's compliance to aseptic procedures and practices in accordance with current regulatory requirements and industry guidance. This position will report to the Associate Director for QA Microbiology.

Essential Duties and Responsibilities include, but are not limited to, the following:

  • Provide support for investigations pertaining to microbial contamination to ensure identification of effective root-cause analysis, assignment of appropriate corrective actions and determination and remediation plans.
  • Engage directly with site personnel to promote an aseptic operations culture and to provide microbiological subject matter expert knowledge.
  • Provide microbiological support to the internal audit and inspection readiness programmes
  • Provide support for tracking and implementation of corrective and preventative actions related to microbiology and aseptic operations.
  • Support resolution of problems identify trends and determine system improvements.
  • The candidate must be familiar with implementation of microbiological environmental monitoring programmes and must understand interpretation of microbiological data including evaluation of trends.
  • Provide microbiological evaluation of site change controls.
  • Support the review and approval of microbial control related documents, including but not limited to, SOPs, validation and qualification documentation, study protocols, and deviation/investigations.
  • Communicate updates, metrics and outstanding items to senior personnel when necessary.
  • Provide assurance of consistency of IOPS Microbial programs and initiatives across multiple sites.
  • Perform additional tasks as directed by senior management.

Education and Experience:

  • Requires BS degree in Life Sciences or related field and at least 8 years of relevant experience, preferably in the pharmaceutical or biotechnology industries. Experience should also include quality control microbiology, critical utilities and involvement with supporting regulatory inspections.

For more information please contact Kathryn on 016455250 or email