QA Specialist, Sterile Manufacturing
LS-1815
Open
Location
Salary
Contract
Permanent
Work model
On-site
Seniority
Mid
Closing date
The role
A sterile fill-finish site in the greater Dublin area is adding to its quality assurance team as it works through the operational implications of the revised Annex 1. This is a floor-facing QA role rather than a desk one.
Day to day you would be reviewing batch documentation, supporting deviation and CAPA investigations, performing routine gowning and aseptic technique assessments, and providing quality oversight on the line. The contamination control strategy work is live and you would contribute to it directly.
The team is eleven strong and the site has a stable inspection history. This is a good environment for someone who wants sterile experience that will travel well.
What you will need
Two or more years in QA within a GMP pharmaceutical manufacturing environment
Direct experience of sterile or aseptic manufacturing
Working knowledge of EU GMP Annex 1, ideally including the revised requirements
Batch record review experience and confidence challenging what you find
Deviation investigation and CAPA experience using structured root cause tools
Degree in a science or pharmaceutical discipline
Comfortable gowning into a grade B environment
What is on offer
Salary of €55,000 to €65,000 depending on experience
Annual bonus of up to 10%
Private health insurance
Pension at 7% employer contribution
25 days holiday plus public holidays
Funded professional membership and study support
Apply for this role
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