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Über
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**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. xcfaprz
* High proficiency in statistical techniques, data review and analysis.
**Desirable:
**Gamma and Ethylene Oxide sterilization experience#IJTravel Percentage: 10%
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Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.