Seeking a Manufacturing QA Compliance Analyst to join my clients dynamic Aseptic Quality team in Westport, Co. Mayo, on a fixed-term contract (12-months). Potential for extension based on performance.
This role involves shift work, with the successful candidate working 12-hour rotational shifts to support our around-the-clock manufacturing operations.
As the newest addition to the Aseptic team, in the capacity of Manufacturing QA Compliance Analyst, you'll be responsible for providing real-time oversight on the shop floor for Aseptic operations, including manufacturing, sampling, and testing.
You'll collaborate closely with colleagues on-site to foster a culture of excellence in Aseptic operations, striving for continuous improvement.
You will :
• Lead Aseptic Operations, ensuring adherence to procedures and driving performance improvement.
• Monitor and provide feedback on shift team behavior, promoting a culture of accountability.
• Review Batch Record documentation and oversee critical activities such as cleaning and setup.
• Support training and mentorship initiatives, fostering a culture of learning.
• Drive continuous improvement in Aseptic procedures and performance site-wide.
• Provide input on EM data assessment and contribute to contamination control strategies.
• Participate in audits and reviews, ensuring compliance and identifying areas for enhancement.
• Collaborate with cross-functional teams to address Aseptic-related challenges and initiatives.
What do you need for this role?
• Third Level Degree in a Science, Quality or Engineering discipline.
• 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally
• Strong knowledge of Regulatory Requirements
• Excellent communication skills