Job Summary:
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This role is a critically important activity to ensure efficient and effective compliant operation in our Drug Substance facility. This person will be key in the day-to-day planning and running of lab testing to ensure the process is streamlined and in line with lean methodologies.
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* Develop and implement quality management systems to ensure compliance with regulatory requirements.
* Plan and perform multiple, complex routine/non-routine methods and procedure when required.
* Provide technical guidance and apply expertise and critical thinking to help to resolve technical issues.
* Lead training of staff on technical aspects of the role.
* Revise and implement procedures that comply with appropriate regulatory requirements.
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Key Responsibilities:
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- Work as directed by the Quality Control Microbiology Manager, according to Company safety policies, cGMP and cGLP.
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- Drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions.
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- Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
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Requirements:
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- Third Level science qualification (Microbiology is preferred).
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- 3 to 6 years' relevant experience.
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- Experience and critical skills in the area of expertise that add value to the business; ideally analytical microbiology, in a GMP setting.
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What We Offer:
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A competitive salary and benefits package, including flexible working arrangements and opportunities for professional development.
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About Us:
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We are committed to creating a work environment that supports diversity, equity, and inclusion.