The QC Microbiology Analyst will support start-up of the Bulk Drug Facility in Dublin. The role will particularly focus on cleaning validation with emphasis on TOC method validation and routine testing of Cleaning Validation samples.
The successful candidate will be responsible for:
· Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
· Compiling protocols and reports.
· Validation of TOC methods to support cleaning validation activities on site.
· Support testing of Microbiology and TOC samples on a routine basis.
· Review and interpretation of test results and trends
· To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
· To keep management updated on issues arising within the laboratory.
· To participate in the training of QC and Manufacturing colleagues as required.
· Investigate out of specification/limit results in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments.
· Technical competency in microbiology and/or analytical method validation.
· Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
· Problem solving and root cause analysis skills.
· Organizational skills.
· Planning/scheduling of own work to meet required timelines.
· Excellent written and oral communication skills.
· Flexible and adaptable
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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