Kelly Services are recruiting for a Senior Microbiologist for a Dublin based pharmaceutical company on a temporary basis until the 10th of April 2021.
.The Site Microbiologist is responsible for ensuring that the testing and management of the Microbial process is controlled and maintained to ensure that products produced of the appropriate quality and safety of the products manufactured. The results of this testing is critical to ensure the safety of the products produced.
Essential Duties and Responsibilities:
* Performance of the microbiology laboratory in routine and non- routine product testing and environmental microbiology testing
* Generation and approval data generated from microbiological testing and to bring any out of specification (005) results/trends to the attention of the team manager
* Provide assistance to management in investigating out of specification/trend results for microbiological data as well as identifying and developing corrective actions for out of compliance issues
* Contribute ideas and suggestions to improve standard laboratory techniques, improve protocols, processes and equipment
* Execute microbiological validations as needed for products and processes
* Ensure products and processes with Micro laboratory comply with procedures and the principles of GMP
* Support and assist in internal and external audit program.
n Conduct training related to environmental control for the Quality and Manufacturing Personnel
* Development of microbial related procedures, controlled documents and processes
* Assist in Risk Management of the microbial systems and processes
n Support facility projects including process development and quality improvement initiatives
* Compliance to Environmental Health and Safety (EHS) requirements
n Support role to the Regional Sterility Assurance personnel with respect of global sterility assurance commitments
n Supporting the development and implementation of the EMPQ sterility Assurance process
* Providing trend review and comment on the EM processes
* Compliance to Good Manufacturing Practices (GMP)
* Compliance to Environmental Health & Safety (EHS) requirements
* Quality of the testing carried out, the results reported, trend analysis product and process improvement initiatives
n Communication of results, trends, 005 reporting in a timely manner both internally and externally
n To directly influence the course of actions proposed to address microbial issues identified
* To liaise directly with supplier laboratories with regards to sampling, testing and results as well as assisting in auditing of these suppliers
* To contribute and assist in the development of new testing and techniques. To bring in-house testing where possible
* To develop existing techniques and improve the processing and reliability of the testing carried out
To maintain an up to date knowledge of micro testing and techniques by seeking within and outwardly new levels of competencies.
* To work actively within team initiative within the Sandyford site and to lead/support Microbial led initiative
* Degree in Science with a speciality in Microbiology
* Post qualification experience of at least 3 years
* Knowledge of GMP desirable
* Experience in a Project based environment work desirable
* Experience of implementing changes and process development
Previous experience in an aseptic manufacturing facility desirable
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.