Quality Control Microbiologist
AS22224
Contract – 18 months
Cork
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone looking to join a leading multinational known for excellence in the field.
This role is responsible for ensuring that all microbiological and sterility testing related to API testing is performed according to established procedures and specifications. The position involves not only laboratory operations but also encompasses process validation, cleaning validation, method validation/transfer, environmental monitoring, and support for aseptic manufacturing.
Duties:
1. Support the QC Micro Team leader with daily testing operations.
2. Review and approve data and QC investigations.
3. Review specifications and coordinate with LIMS scheduling.
4. Approve nonconformances, CAPAs, and change control records.
5. Lead lab projects such as method transfer, optimization, and equipment qualification.
6. Identify and implement process improvements in the lab.
7. Train team members on microbiological technologies.
8. Provide technical support and expertise on microbiological methods.
9. Support lean initiatives, including documentation updates and equipment qualification.
10. Present analytical data clearly to internal teams and regulators.
11. Draft, review, and approve technical documents like protocols and specifications.
12. Stay updated on microbiological technology and compliance trends.
13. Collaborate with the team to resolve microbiology-related quality issues.
14. Coordinate with other departments on environmental and utilities monitoring programs.
15. Support aseptic manufacturing operations, including sterilization, autoclaving, and gamma irradiation processes.
Experience and Education:
* Minimum of a degree in Microbiology or related Science field, with at least 5 years of relevant pharmaceutical industry experience.
* Knowledge of industry regulations (FDA, HPRA, EMEA) and application thereof.
* Experience managing projects or leading teams.
* Proficiency in microbiological techniques such as sterility testing, bioburden, endotoxin testing, and environmental monitoring.
* Understanding of regulatory requirements for pharmaceuticals and aseptic processes.
Please note that if you are not a passport holder of the country for the vacancy, you might need a work permit. Check our blog for more information.
Bank or payment details should not be provided when applying. All applications should be submitted via the 'Apply now' button.
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