Quality Control Micro Analyst
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| Job Type | Contractor |
| Area | Dublin, Ireland |
| Sector | Laboratory/Scientific |
| Start Date | |
| Advertiser | Mary King |
| Job Ref | 2359 |
| Job Views | 1245 |
- Description
- We are seeking applications for an experienced Quality Control Micro Analyst for our client, who are a leading biopharmaceutical company based in Dublin. You will support with emphasis on microbiological sampling and testing as well as technical support with regard to method validation, regulatory updates and new technology.
Why you should apply:
· This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
· Our client has developed a stand-out culture of innovation, inclusion and development, and consistently features as a great place to work.
What you will be doing:
· Environmental and facilities monitoring sampling and testing.
· Keeping to schedules and targets and making sure standards are maintained
· Validation/Qualification of Microbiology test methods and test systems
· Representing in audits where appropriate.
· Close out of actions/ recommendations identified from audits.
· Helping to that compliance is evaluated and training is provided where appropriate.
· Keep up to date with all new technologies, procedures and methods used in the microbiology laboratory.
· Technically reviewing data, validation protocols and reports.
· Providing technical support through project participation, investigation, validation and testing activities and prepare technical reports as required.
· Making sure all instruments/equipment are maintained in a calibrated and operational state.
· Adhering to a high standard of housekeeping and safety.
· Carrying out project work and delivering initiatives designed to improve the efficiency of the laboratory function/department.
· Keeping management informed on issues.
· Scheduling of testing, review and authorization of microbial data.
· Investigate out of specification/limit results to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
· Training laboratory staff and play appropriate role in the development, operation and evaluation of training/re-training programs.
· Any other duties as required by management.
What you need to apply:
· 1+ years’ experience in cGMP Quality environment.
· Testing experience of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
To be up to date on regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing
