Microbiologist

Job Description

Title: Microbiologist
Location: Clonmel Tipperary

Job description for a microbiologist role:

I'm looking for someone with around 10 years of experience in Irish pharma companies, who can lead the Microbiology department independently with the assistance of a junior microbiologist.

Candidates with experience working in testing laboratories such as Eurofins/CLS and the ability to handle large sample volumes are more suitable.

➢Preparing Validation Protocols and executing Product Validation activities related to Microbiology.

➢ Preparation and review of SOPs, GTPs, STPs, IOCPs, Miscellaneous study protocols and reports.

➢ Responsible for Microbial Testing and Review of Water, RM, Packing Material, In-process, Finished Product, and Stability samples.

➢ Microbial limit testing and method validations of Raw materials, Hold time samples, Finish products, and Stability samples.

➢ Production and Microbiology area environment monitoring (Active and Passive Air Sampling, Surface Monitoring) of Oral Solid Dosages Manufacturing.

➢ Microbial analysis (TAMC and Pathogen Testing) of water samples (Purified/ WFI/ Pure Steam/ Raw/ Potable Water).

➢ In-process, finished product, and Packing material Bioburden test performed.

➢ Bacterial Endotoxin Testing and Method Validation.

➢ Media Preparation, Sterilization, and Growth Promotion.

➢ Laboratory equipment/ instruments Calibration.

➢ Responsible for investigating excursion results during environmental monitoring and water Analysis.

➢ Review of Equipment, Instrument, Utility Systems Qualification, and Verification of electronic data generated at the laboratory during testing and software

➢ Review Audit trail of Equipment, Instrument, and systems software.

➢ Thorough understanding of USP/NF, EP, and BP testing

➢ Handling of QMS activities like Change Control, Events, Deviation, Investigation and CAPA.

➢ Review Good Laboratory Practices to Ensure GMP Compliance, Laboratory Compliances, and inspection readiness at Site.