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Sterile Plant Quality Assurance Expert
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Merck Gruppe - MSD Sharp & Dohme is a global leader in the pharmaceutical industry, dedicated to delivering innovative treatments that improve patient outcomes. Our commitment to excellence is reflected in our state-of-the-art facilities, cutting-edge technologies, and rigorous quality control processes.
Job Summary
We are seeking a highly experienced Associate Director, Site Microbiologist to join our team in Carlow. The successful candidate will lead our microbiological efforts, ensuring compliance with regulatory requirements and maintaining the highest standards of quality and safety.
Key Responsibilities
1. **Leadership and Guidance**: Provide expert guidance on microbiological procedures and best practices to ensure compliance and operational efficiency.
2. **Technical Document Development**: Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
3. **Risk Management**: Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies.
4. **Inspection Readiness**: Support the inspection readiness program, ensuring microbiological practices meet regulatory and internal compliance standards.
Requirements
To be successful in this role, you will require:
1. A Bachelor's degree in microbiology or a relevant discipline.
2. Relevant experience at this level in site microbiology or a related area.
3. Strong understanding of microbiological principles and practices, ideally in a sterile plant environment.
4. Expertise in Eudralex Annex 1 requirements.
5. Experience in technical appraisal, document review, and audits.
6. Excellent analytical and problem-solving skills.
7. Strong written and verbal communication abilities.
8. Proven experience in root cause analysis and risk management.
What We Offer
This is an exciting opportunity to work with a talented team of professionals who share your passion for microbiology and quality assurance. You will have the chance to contribute to our mission of delivering life-changing medication to patients around the world.
