Senior Microbiologist

Excellent contract Project Microbiology role focussing on providing technical input into the sterility compliance of Products.

Apply to Rachel@rtlanerecruitemtn.ie or call 087 9669394 for more details.

Role:

• Oversight of environmental & utility monitoring, bioburden and endotoxin testing practices and procedures, creating alignment and standardization across multi sites.
• Interpreting sampling and monitoring data, applying statistical and analysis techniques, to determine control and trending.
• Lead technical input to NC and CAPA resolution within the Microbiology group and across multiple business units / sites. Strong competency in assessment of effectivity and resulting sterility compliance. Review and approval of CAPA.
• Act as technical lead for microbiology in cross functional groups including product and process issues, root causing, projects, initiatives and other business critical forums..
• Subject Matter Expert, audit and review of Supplier quality activities with critical vendors in area of microbiology.
• Review and approval of sterilisation validations and re-qualifications in line with relevant BS EN ISO standards. Assessment of sterility supplier validation.
• 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).

Education:

• Minimum of 8 years in Quality/Regulatory Affairs environment.
• Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
• Lead auditor certification desirable.
• Thorough knowledge and understanding of US and International Medical Device Regulations