Posted: 12 July
Offer description
We are seeking a highly skilled Microbiologist to join our team in Cork. The successful candidate will be responsible for ensuring the microbiological and sterility testing associated with API testing is performed according to procedures and specifications.
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* Supports the Quality Control Team on day-to-day testing operations.
* Performs data and quality investigations, reviews, and approvals.
* Reviews specifications and plans for associated LIMS scheduling.
* Reviews and approves nonconformances, CAPAs, and change control records.
* Plans and oversees laboratory-related projects, such as method transfer and optimization, equipment qualification, etc.
* Identifies and drives lab process improvements proactively.
* Provides superior technical support on specific microbiological technologies.
* Supports lean initiatives in laboratory operations, such as standard work, level loading, test method execution, documentation updates, and equipment qualification, etc.
* Presents analytical data clearly and concisely to customers, internal investigations, and regulatory inspectors.
* Writes, reviews, and approves technical documents, e.g., protocols, APRs, specifications, filing documents.
* Stays up-to-date with microbiological technology and compliance trends.
* Resolves microbiology-related product quality issues with the Quality Control Team Leader.
* Liaises with other departments to develop and maintain site environmental monitoring and critical utilities programs.
* Supports the Aseptic Manufacturing facility, including routine manufacturing operations, isolator operations, autoclave operations, gamma irradiation, CIP, and SIP.
Requirements:
* At least a primary degree in Microbiology or a Science discipline with at least 5 years of experience in the Pharmaceutical Industry or relevant experience as a Microbiologist.
* Demonstrated knowledge and application of industry regulations, including FDA, HPRA, EMEA, and other applicable authorities.
* Experience managing project groups or leading teams.
* Expertise in various analytical techniques, including sterility testing, bioburden, endotoxin techniques, autoclave, environmental, and utilities testing, and gamma irradiation.
* Knowledge of FDA/EMEA regulatory requirements.
