Duties & Responsibilities
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Provide microbiological support to the site, ensuring the execution of analysis in a GMP environment. This involves:
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* Developing, maintaining, and updating microbiological methods, specifications, and SOPs in compliance with quality and regulatory requirements.
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* Trending data, monitoring Out of Specifications, and participating in laboratory investigations.
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* Testing In-process, Drug Substance, and Drug Product Batches manufactured.
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* Coordinating all site Utilities testing-environmental monitoring and water testing programmes.
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* Leading environmental investigations, root cause analysis, and reporting close out.
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* Presenting monthly environmental review meetings and trends to a cross-departmental team.
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* Providing annual contamination control training to all personnel.
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* Providing aseptic technique training to all new employees.
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* Validating microbiological methods, such as bioburden and endotoxin.
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* Supporting autoclave validation programme.
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* Conducting stability testing of Drug Substance and Drug Product Batches.
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* Participating in Quality and Safety regulatory audits.
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* Supporting raw material testing for GMP manufacture.
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* Inputting into equipment requirements and collaborating with vendors for qualification and validation.
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* Troubleshooting equipment and techniques within the Analytical team.
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* Participating in other projects/duties defined by the Quality Director.
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POSITION SPECIFICATION
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This role requires:
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* A third-level degree in a life Science discipline.
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* 2-5 years' experience in a microbiology role, including environmental monitoring, utilities testing, bioburden testing, and endotoxin testing.
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* Experience in validating microbiological methods.
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* Strong analytical and technical skills.
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* The ability to learn quickly and take responsibility for tasks/projects.
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* A highly organized and structured approach to task completion.
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* Strong time management awareness and the ability to drive projects forward.
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* Excellent verbal and written communication skills, including presenting work in clear, concise reports or presentations.
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Legal Statement
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This job description indicates the general nature and level of work expected. It is not designed to cover or contain a comprehensive listing of activities or responsibilities required of the incumbent. The incumbent may be asked to perform other duties as required. Additional position-specific requirements/responsibilities are contained in approved training curricula.
Summary of our Benefits
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In addition to being part of a world-leading animal health company focused on the needs of those who raise and care for animals, we offer:
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* Competitive salary.
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* Bonus.
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* 25.5 days holiday per annum plus public holidays.
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* A defined contributory pension plan.
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* Private medical insurance for you and your family.
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* Empowered flexible working.
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Requirements
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To be considered for this role, please complete the application process on our careers page. To start, click the Apply button below to Login/Register.