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QA Manufacturing Compliance Analyst, Mayo
Client:
TEAM HORIZON
Location:
Mayo, Ireland
Job Category:
Other
EU work permit required:
Yes
Job Reference:
62a3fd72c50d
Job Views:
9
Posted:
15.03.2025
Expiry Date:
29.04.2025
Job Description:
Team Horizon is seeking an experienced QA professional to join our client’s aseptic facility on a Fixed Term Basis as a QA Manufacturing Compliance Analyst.
Why you should apply:
1. As the newest member of the Aseptic team, you will provide real-time shop floor oversight to Aseptic operations, partnering with Site colleagues to create an environment of the highest performance standards of Aseptic operations and driving continuous improvement in Aseptic Operations on site.
2. This is an excellent opportunity to join a company that puts their people and their patients first.
3. Make a lasting impact that's felt within healthcare and beyond.
What you will be doing:
1. Act as site Subject Matter Expert for Aseptic Operations (Manufacturing, sampling and associated testing).
2. Ensure Aseptic operations are carried out as per Site Procedures.
3. Continuously observe the Aseptic technique and behavior of the shift team, providing feedback as appropriate. Intervention can include a ceasing of manufacturing and testing operations if deemed appropriate. Drive a culture of Speak-Up.
4. Drive all aspects of Aseptic Performance of the shift team through observation and feedback.
5. Drive all aspects of Aseptic performance during sampling and testing.
6. Partner with Aseptic Mentors and Shift Supervisors to drive performance of the shift team.
7. Complete real-time review of Batch Record documentation.
8. Support training activities and actively coach and mentor colleagues who work in Cleanrooms.
9. Provide Quality Oversight during critical Aseptic activities such as Cleaning, Sanitization, Aseptic Set-up, sampling, EM plate handling, sample testing and Interventions.
10. Participate and provide leadership to the Site Aseptics team, highlighting and leading introduction of continuous improvement in Aseptic procedures.
11. Provide input and guidance on changes related to Aseptic Manufacturing, sampling and associated testing.
12. Drive a high-performance Aseptic culture across the site.
13. Actively lead and support investigations.
14. Review and Audit Batch Records real-time.
15. Review and Audit Manufacturing and Testing logs as required.
16. Complete Line Clearance activities.
17. Participate in routine leadership GEMBAs of Manufacturing and Laboratory area.
18. Provide key input to the development and maintenance of the Site Contamination Control Strategy.
19. Provide key input to the assessment of EM data and trends.
What you need to apply:
1. Third Level Degree in a Science, Quality or Engineering discipline.
2. 5+ Years of experience in a GMP Environment with 3+ years of experience in support of Aseptic Manufacturing ideally.
3. Strong knowledge of Regulatory Requirements.
4. Excellent communication skills.
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