QC Micro Analyst Job -Dublin
QC Microbiologist Job - take the next step……..
A leading pharmaceutical company in Dublin West now has a fantastic opportunity for a QC Microbiologist to work in a FDA regulated environment .This award winning company has an excellent history of employee, continuous professional development and business continuous improvement.
QC Microbiologist Job
You will ensure all testing & quality requirements related to all products meet company guidelines. You will also provide technical leadership to junior analysts and work to establish appropriate systems to ensure departmental compliance with regulatory requirements.
- Oversee microbiology and coordinate sampling activity in support of routine testing.
- Coordinate and priorities laboratory activity in support of routine testing, product release, product shelf-life, process non-conformances, complaint investigations, regulatory submissions
- Act as a technical expert and approval authority on relevant technical issues, protocols, SOPs, methods,
- Implement cost improvement projects within department and in support of internal customers.
- Perform microbiological testing
- Participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence.
- Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- Perform environmental monitoring as required to support operations.
- Track, report, & improve key quality indicators for laboratory compliance and efficiency.
- Perform other related duties as assigned by management.
- Acts as the contact for regulatory groups on scientific issues and audits.
- Level 8 Bachelor's Degree in a science related field.
- 4 years' experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
- Experience of working in a GMP environment.
- Thorough knowledge of FDA and International Regulatory requirements.
- Excellent organizational, interpersonal, written and oral communication skills required.
- Ability to work on own initiative and flexible work ethic
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For a confidential discussion please contact Felicity on 086 7821714