The QC Microbiology Analyst will support the Bulk Drug Facility in Dublin with emphasis on microbiological testing such as Environmental Monitoring, Water, Gas and raw materials sampling and testing, Bioburden and Endotoxin, technical support with regard to method validation, regulatory updates and new technology.
The successful candidate will be responsible for: Environmental and Facilities monitoring sampling and testing.
- Ensuring high cGMP, GLP standards are maintained while testing and adherence to schedules and targets to meet regulatory and business requirements.
- Validation/Qualification of Microbiology test methods and test systems such as the Endotoxin test system and Identification system.
- Represent the Microbiology department in internal and external audits where appropriate.
- Close out of actions/ recommendations identified from both internal and external audits.
- Assist in ensuring that current compliance issues and trends, both internal and site-wide, are critically evaluated and training is provided where appropriate.
- To maintain competence and keep up to date with all new technologies, procedures and methods used in the Microbiology Laboratory.
- Perform technical review of data generated in laboratory, validation protocols and reports. Provide Technical support to Manufacturing and Projects which the company undertakes through project participation, investigation, validation and testing activities and prepare Technical Reports as required.
- To ensure all instruments/equipment are maintained in a calibrated and operational state. To ensure a high standard of housekeeping and safety is maintained in the Laboratory.
- Completion of project work and implementation of initiatives designed to improve the efficiency of the laboratory function/department.
- To keep management updated on issues arising within the laboratory. Scheduling of testing, review and authorization of microbial data.
- Investigate out of specification/limit results utilizing Structured Problem Solving, Root Cause Analysis tools in conjunction with the Microbiology Laboratory Supervisor, QA and other relevant departments and to implement effective corrective and preventative actions while ensuring all investigations are closed with the specified lead-time.
- To train laboratory personnel and play appropriate role in the development, operation and evaluation of training/re-training programs.
- Minimum of 1 year experience in cGMP Quality environment.
- Experience in testing of sterile drug product and aseptic filling process of sterile pharmaceutical /biopharmaceutical products.
- Good knowledge of current regulatory requirements for Microbiology / Sterility Assurance in support of cGMP operations supporting clinical and commercial manufacturing.
- Competencies Success in the role is dependent on demonstrating the following competencies: Technical competency in Sterility Assurance, Aseptic filling and microbiology methods.
- Ability to develop collaborative relationships with other functions and sites in order to achieve functional, site and company goals.
- Problem solving and root cause analysis skills.
- Organizational skills.
- Planning/scheduling of own work and subordinates and ability to delegate tasks where appropriate. Excellent written and oral communication skills.
Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.
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