Our client a large MNC requires an experienced Microbiologist for a permanent role in Cork. This position is responsible for technically supporting QC and Operations Microbiological activities
Duties and Responsibilities
- Actively supports Process microbiological investigations.
- Perform Risk Assessments for projects and business innovation initiatives from a microbiological perspective.
- Drives strategy improvements related to the reduction of contamination risks and the improvement of microbiological hygiene.
- Defines specific aseptic techniques to be performed for crucial process steps and provides meaningful input to processing operations.
- Play a lead and proactive role in the design, maintenance and delivery of Operations aseptic technique and microbiology awareness training programmer. In conjunction with manufacturing help improve training related to microbiological hygiene and contamination prevention.
- Periodic review of site trends (Utilities) and support identification of appropriate corrective and preventative actions as required. (I.e. critical utilities team).
- Ensuring activities are carried out in compliance with cGMP and company quality standards.
- Participate in relevant internal and external QC related audits.
- Support effective design and deployment of QC micro analyst training program.
- Ensure the design and qualification of QC testing is according to GMP
- Understand and support current regulatory trends and future testing requirements.
Education, Experience and Skills:
- BSc in a scientific/technical discipline required.
- A minimum of 5 years' experience within the biological and/or pharmaceutical industry.
- Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
- Possess a detailed knowledge of the shop floor manufacturing process.
- Possess a comprehensive knowledge of trending using statistical analysis.
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals.
For further information on this Microbiologist role in Cork please contact BImi Felix on 091730022 / firstname.lastname@example.org
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