Work Flexibility: Onsite

12 month fixed term contract - onsite in Carrigtwohill

Who we want:

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

What you will do:

• Environmental monitoring of cleanrooms for viable air, viable surface and particulate in line with ISO 14644 standards.
• Monitoring of utilities including all grades of water, and where necessary, compressed air.
• Co-ordination of samples for bioburden and endotoxin testing.
• Ordering consumables (media etc) and general stock for day-to-day running of laboratory.
• Applying cGLP to all laboratory activities including stock control.
• Performing sampling for validations and re-qualifications as required. Review of validation files for compliance.
• Strong interactions, maintenance and support of sterility suppliers.
• Interpreting sampling and monitoring data, applies statistical and analysis techniques, to determine control and trending.
• Leads NC and CAPA generation and resolution within the Microbiology group and across related business units. Strong competency in troubleshooting, correction of NC and root cause analysis.
• Performs sterility release review, interpreting data and trends.
• Continually identifies opportunity for stabilization of trends, statistical control of processes to allow cost saving.
• Mentors and trains team and cross functional groups as required (induction, GMP etc)
• Subject matter expert to local procedures, contribute to the development, maintenance and improvements of the policies and procedures to align to best practices, benchmarking against industry leads and regulatory requirements.
• Coach, mentor and train other functions in area of sterility and monitoring.

What are we looking for:

• Bachelor’s degree/ Master of Microbiology or equivalent
• Minimum of 6 years in Quality/Regulatory Affairs environment or 6 years Microbiology related experience.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
• Must possess effective communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneously.
• Strong interpersonal skills.
• Strong written and oral communication and negotiations skills.
• Strong in critical thinking and "outside the box" thinking.
• Highly developed problem-solving skills.
• Strong analytical skills.
• Demonstrated ability to successfully manage and complete projects in a matrix organization.
• Demonstrated ability to work independently.
• Experience in working in a compliance risk situation.
• High proficiency in statistical techniques, data review and analysis.

Desirable:

Gamma and Ethylene Oxide sterilization experience:

#IJ

Travel Percentage: 10%