QA Associate
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Location:
Cork
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Contact email:
mtully@sigmar.ie
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Sector:
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Contact phone:
+353212359144
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Job type:
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Job ref:
MTllyBM22
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Salary:
Negotiable
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Published:
4 months ago
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Contact email:
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Consultant:
Job description
About Your New Employer
My client is the world leader in delivering first-in-class therapies for rare genetic diseases.
They are now hiring a QA Associate to join their ever-growing team for a 23-month contract.
Operating across 4 continents they have an appetite for science, which drives them to provide life-changing results for their patients worldwide.
They have a skilled workforce that is collaborative, curious and shares a passion for shared accomplishments.
About Your New Job
- Provide QA support to the site for drug substance GMP operations (Warehouse/material operations, Upstream/Downstream and Support Services manufacturing, Automation and Process Engineering, MES, QA Validation and Capital Projects).
- Review of MES Exceptions.
- Support lot release activities/schedule including preparation of BDS/FBDS lot files.
- Release of Raw Materials for drug substance production.
- Review and approve deviations and QC LIR reports to ensure that root causes have been identified, appropriate corrective actions have been implemented and appropriate impact assessments are complete.
- Review and approval of process and equipment validation/qualification protocols/reports.
- Support and drive Continuous Improvement/Lean initiatives on site.
What Skills You Need
- Level 8 honours degree Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences, pharmacy) is required.
- Minimum 3-5 years of relevant experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in Quality Assurance and Regulatory Compliance.
- Experience using MES, Trackwise and Veeva programmes.
- Demonstrated ability in problem-solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations.
- Ability to coach junior QA staff.
- Strong ability to communicate, make decisions, present data, and defend approaches in front of audiences and inspectors.
- Experience with batch release activities is an advantage.
What’s on Offer
- Full time – 39 hours p/w – 23-month contract.
- Shift role - 6-week cycle including 1 week of earlies and 1 week of lates with 4 weeks of days. Earlies = 06:30am-14:30, lates = 14:30-22:30 (Friday 06:30am-13:30, 13:30-20:30)
- 25 days annual leave.
- Salaried – monthly paid.
What’s Next
- For a confidential discussion on this or any other current job opportunity please contact Meggan Tully on 087-7631660/mtully@sigmar.ie.
Why Apply Through Sigmar?
- We’ll help manage your job hunt, strengthen your interview skills and tidy up your CV
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