|Sector||:||Scientific & Laboratory|
Role of this position
- Responsible for QC microbiological aspects of cGMP compliance and testing.
- Perform microbiological validations as needed for finished product and in process controls and buffers.
- Assist in the identification of microbiological root cause analysis and provide technical advice as needed
- Participate in the investigation and review of alert and action limit investigations as needed and implements corrective action as appropriate.
- Participate in cleaning and process validation activities involving microbiology as needed.
- Contribute to the preparation of technical proposals, amendments, reports and memoranda.
- Contribute toward creating and revising microbiological SOPs
- Assist in the review of EM and product release data
- Microbiology representation and participation in cross functional site meetings.
- Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc
- Initiates and completes CAPAs and Change Controls in accordance with site procedures.
- Proactively identifies and implements lab process improvements, lean initiatives.
- BS/BA in a scientific/technical discipline preferably Microbiology
- 5+ years of relevant experience, preferably in a QC Microbiology Laboratory preferably within the pharmaceutical or biotechnology industries
- Experience with electronic systems such as LIMS, Qumas, eDoc, Trackwise etc., is an advantage.
- Preferred Laboratory Experience: Microbiology, Bioburden, Endotoxin, Microbial Identification, Utility Sampling, Environmental monitoring, Cleaning and validation studies, Familiar with USP, JP and EP methodology
Please call Gillian Dunphy today for further information on 061-365969 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)
Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.