Our client, a pharmaceutical company in Mayo are currently looking to recruit a Senior Microbiology Manager for their site.
Responsible for planning, supervision and control of a Microbiology Laboratory by:
- Managing microbial testing of raw materials, in-process and final products.
- Managing cleanroom and utilities microbial monitoring; ensuing cleanrooms operation as per design intent and utilities providing appropriate quality for product manufacture
- Ensuring the laboratory is operated in a safe manner
- Ensuing an effective quality management system is in place within the laboratory; ensuring appropriate root cause analysis is performed for any deviations and an appropriate investigation and impact assessment completed for any out of limits from within cleanrooms
- Supporting and Coaching of Laboratory Supervisors and Technicians, providing motivation to the team and take appropriate corrective action on individual/team performance where required.
- Ensuring SOPS are followed and comply with industry requirements and industry best practices
- Ensure testing is completed in line with EP/USP and registered specifications
- That the environmental monitoring and utility monitoring is supported with environmental monitoring risk assessments
- Supporting contamination control strategies for cleanroom operation
- Manage and contribute to the site quality goals as they relate to the Microbiology laboratory
- Perform assessments of personnel activities versus the SOP to ensure compliance
- An active member at presenting at quality management and trend meetings
- Involved in corporate and regulatory audits; presenting the tasks of the Microbiology laboratory
- Work closely with the production management team on site; providing assistance in investigation of contamination events and supporting batch assessment and CAPA.
- Accountable for supporting Microbiology Laboratory Supervisors and Technicians
- Accountable for Quality System within the laboratory; ensuring timely completion of reports and investigations and written to a high standard
- Ensuring all testing is performed within defined timelines, is performed as per SOP and SOP is compliant with regulatory requirements
- Ensuring effective monitoring and control of cleanrooms and utilities and contamination control strategies are supporting sterile manufacturing
- Scientific Microbiological Qualification
- 5 years’ experience within Microbiology GMP environment
- 2 years’ experience in a management role
- Strong background in Microbiology and Cleanroom operation
- Extensive knowledge of microbiology tasks and associated regulatory standards and guidance.
- Ability to anticipate, understand and address the changing regulatory environment of the industry.
- Assess implications of new regulatory guidance and implement necessary changes as they relate
- to Microbiology.
For further information on this Senior Microbiology Manager role in Mayo please contact Clara Burke on 086 8168273 / email@example.com
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