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
1. Serve as the Subject Matter Expert (SME) for all plant microbiological concerns, providing guidance and support to various departments.
2. Share expertise on microbiological procedures and best practices to ensure compliance and operational efficiency.
3. Participate in microbial-related investigations, contributing to root cause analysis (RCA) teams to identify issues and develop preventive actions.
4. Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
5. Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies.
6. Support the inspection readiness program, ensuring microbiological practices meet regulatory and internal compliance standards.
Who You Are
You are ready if you have
1. Bachelor’s degree in microbiology or a relevant discipline.
2. Relevant experience at this level in plant 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.
So, if you are ready to Invent solutions to meet unmet healthcare needs, please apply today.
Employee Status: Regular
Relocation: Not specified
VISA Sponsorship: Not specified
Travel Requirements: Not specified
Flexible Work Arrangements: Hybrid
Job Posting End Date: 01/28/2025
A job posting is effective until 11:59:59 PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID: R328467
#J-18808-Ljbffr