Senior Microbiologist Position
A Senior Microbiologist is required to join our team of experts in the pharmaceutical industry.
This is an 18-month contract opportunity that will allow you to utilize your skills and experience in a sterile environment.
* Supports Quality Control Micro Team leader on day-to-day testing operations.
* Performs Data and QC Investigations review and approval.
* Reviews Specifications and plans for associated LIMS scheduling.
* Reviews and approves Non conformances, CAPAs and Change Control records.
* Plans and oversees lab related projects, i.e., Method transfer and optimisation, Equipment Qualification etc.
* Proactively identifies and drives lab process improvements.
* Trains laboratory team on specific microbiological technology.
* Provides superior technical support on specific microbiological technology.
* Supports lean initiatives in lab operations, i.e. standard work, level loading, test method execution, documentation updates and equipment qualification etc.
* Presents technical analytical data clearly and concisely to customers, i.e., internal investigations and regulatory inspectors.
* Writes, reviews and approves technical documents e.g. protocols, APRs, specifications, filing documents.
* Keeps abreast of microbiological technology and compliance trends.
* In conjunction with the QC Micro Team Leader, identify, record and resolve any microbiology related product Quality Issues.
Requirements:
Primary degree in a Microbiology/Science discipline.
3-5 years experience within the Pharmaceutical Industry or relevant experience as a Microbiologist.
Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities applicable to pharmaceuticals and aseptic products.
Experience with Microbiological technologies and methods.
Expert in a wide variety of analytical techniques including but not limited to sterility testing, bioburden and endotoxin techniques, autoclave, environmental and utilities testing, and gamma irradiation.
Knowledgeable of FDA/EMEA regulatory requirements.