Our client, a pharmaceutical company in Mayo are currently looking to recruit a Analytical Technology Specialist III for their site.
To complete a Lifecycle Management assessment of the current microbiology test methods including those employed for sterility testing, antibiotic assay, antimicrobial effectiveness testing, bioburden and microbial limits testing. The assessment will include a review of current pharmacopeia, FDA microbiology manual, PIC guidelines and industry best practices. All formulation will be assessed, to include:
- The constituents of the products
- The test method employed to determine that it does not inhibit growth which would impact on safety and efficacy.
- Previous validations and revalidations of the methods will be included in the scope of the assessment.
- Research on product formulations, pharmacopeia, standards, best practices for Microbiology methods.
- Develop tool for performing assessment of formulations.
- Generation, review and approval of technical documentation.
- Completion of validation activities.
- Investigation / assessment to be completed to ensure compliance to Quality Management System.
- 3 ? 7 years’ experience with a minimum of 3 years’ experience in Microbiology, an advantage would be working in method development/validation
- Competent in a variety of Microbiology techniques
- Good knowledge of Microbiology guidelines including Pharmacopeia, FDA manual, PICs
- Good troubleshooting expertise.
- Knowledge of consumables and equipment available for all types Microbiology testing
- Strong technical writing skills for protocol / report generation
- Excellent communication skills
- Must have an ability to work on own initiative and project plan accordingly
For further information on this Microbiology Specialist III role in Mayo please contact Clara Burke on 086 8168273 / firstname.lastname@example.org
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