Associate Director, Quality Control, Carlow
4 weeks ago
Job Description
Are you passionate about delivering life-changing medication to patients around the world? At our state-of-the-art Carlow site, you will be at the forefront of ensuring the highest standards of microbiological quality and compliance. We are seeking a dynamic and committed Associate Director, Quality Control to join our expanding team.
Your Core Responsibilities
- Serve as the Subject Matter Expert (SME) for all plant microbiological concerns, providing guidance and support to various departments.
- Share expertise on microbiological procedures and best practices to ensure compliance and operational efficiency.
- Participate in microbial-related investigations, contributing to root cause analysis (RCA) teams to identify issues and develop preventive actions.
- Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
- Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies.
- Support the inspection readiness program, ensuring microbiological practices meet regulatory and internal compliance standards.
Who You Are
You are ready if you have:
- Bachelor’s degree in microbiology or a relevant discipline.
- Relevant experience at this level in plant microbiology or a related area.
- Strong understanding of microbiological principles and practices, ideally in a sterile plant environment.
- Expertise in Eudralex Annex 1 requirements.
- Experience in technical appraisal, document review, and audits.
- Excellent analytical and problem-solving skills.
- Strong written and verbal communication abilities.
- Proven experience in root cause analysis and risk management.
So, If You Are Ready To
Invent solutions to meet unmet healthcare needs, please apply today.
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