QC Microbiologist - Ireland
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Helsinn Birex seeks Microbiologist
The Helsinn Group
Helsinn is a privately owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland and the U.S., a representative office in China as well as a product presence in approximately 190 countries globally. Our mission is to bring respect, integrity and quality to our products, services, and all that we do to improve the health and quality of life in every person affected by cancer.
Helsinn Birex Pharmaceuticals, Dublin, Ireland.
This job is based at the Group's finished pharmaceutical manufacturing plant, Helsinn Birex Pharmaceuticals (HBP). HBP operates a state-of-the-art drug product development and manufacturing facility for the production of oral, solid and topical dosage forms. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel which are produced by its worldwide network of CMOs. HBP also acts as the Group's supply chain platform, distributing the Group's products globally.
Over the years, we have been consistently recognized by industry awards both international and domestic, for industrial safety, responsible care and employee wellbeing.
Helsinn is an Equal Opportunity Employer and welcomes applicants who meet the above criteria. No recruitment agency assistance is required for this vacancy.
Job Purpose: The primary purpose of the Microbiologist is to perform microbiological analysis of raw material, in-process and finished product as well as stability and development samples according to the relevant specifications while ensuring the documenting and reporting of same is conducted in accordance with good laboratory practices.
The Microbiologist shall carry out most of his/her duties in the Quality Control Micro Laboratory and the primary tasks and responsibilities of the position are as follows.
Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP.
Receiving and logging samples into the Micro Laboratory.
Performing Micro analysis of raw material, in-process, finished product and stability samples associated with development products according to specifications.
Performing micro analysis of water and environmental samples.
Monitoring Micro trends in a timely fashion.
Liaising with external labs on any micro testing that requires off site testing.
Analysing validation samples according to validation protocols and investigational samples as directed.
Recording results in a timely and accurate fashion.
Ensuring the Right First Time KPI with respect to Analyst’s documentation are achieved.
Ensuring that all Quality Systems within the department are adhered to on a daily basis.
Ensuring correct labelling of laboratory reagents and samples.
Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance.
Training other laboratory staff as requested and appropriate.
The successful applicant will possess the following knowledge, skills, qualifications and experience.
A BSc Degree (life science)
At least 12 months minimum experience working within a pharmaceutical cGLP environment (IMB and FDA approved).
Practical/Working experience of micro testing methods.
Possessing excellent attention to detail is a must with ability to critically review analytical data.
Ability to trouble shoot, identify microbiological issues issues and follow up with corrective actions.
Ability to work on own initiative and in a self directed manner (stand alone position within a larger QC group/ up to 30 people).