Job Title: Microbiology Manager
Location: Westport, Co. Mayo, Ireland
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
- Support ongoing OPEX initiatives within the laboratory and build on imbedded OPEX changes
- Supporting and Coaching of Laboratory Supervisors and Technicians, providing motivation to the team and take appropriate corrective action on individual/team performance where required.
SUPERVISORY RESPONSIBILITY: (IF APPLICABLE)
- 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
- Ensure effective recording, analysis and reporting of Micro KPIs ensuring issues impacting quality performance are addressed.
- Keeping up to date with industry best practices in terms of Microbiology testing and cleanroom monitoring
- 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
- Role to work closely with the production management team on site; providing assistance in investigation of contamination events and supporting batch assessment and CAPA
JOB QUALIFICATIONS (MINIMUM REQUIREMENTS):
- Scientific Microbiological Qualification
- 5 years’ experience within Microbiology GMP environment
Education and Experience
- Scientific Graduate and/or Microbiology Laboratory & Cleanroom Technical knowledge
- 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 pharmaceutical industry. Assess implications of new regulatory guidance and implement necessary changes as they relate to Microbiology.
Essential Skills, Experience, and Competencies (includes Licenses, Credentials)
- Communication and engagement (i.e., presentations and written communications; interviewing & facilitating, and influencing/negotiating/handling conflict)
- Leadership and influencing skills
- Excellent documentation skills
- Excel and PowerPoint proficiency
- Proven to be self-directed, self-motivated and ability to prioritise competing priorities
Please send CV to the following email to firstname.lastname@example.org