Posted 7 hours ago
OOS/Exception Specialist
Eurofins BioPharma Product Testing Leiden B.V.OOS/Exception Specialist
Perks & benefits
Annual LeavePaid Leave
Requirements
BSc or MSc in Biopharmaceutical Sciences, 3+ years deviation management experience, GMP experience, English proficiency
Skills
GMPRoot Cause AnalysisDeviation Management
About the role
Responsibilities
- Immediate troubleshooting after detection of unexpected testing results or irregularities
- Decision making to open Exception or OOS records in eLIMS
- Client notification and follow-up communication regarding OOS or critical Exceptions
- Leading investigations using root cause analysis tools in cooperation with stakeholders
- Proposing (re)testing plans and gathering necessary approvals
- Technical writing and finalization of exceptions in line with GMP guidelines
- Proposing and implementing CAPAs
- Executing (re)training of staff as part of investigations
Requirements
- BSc or MSc in Biopharmaceutical Sciences (Chemistry, Biology, or similar)
- At least 3 years of work experience in deviation management
- Working experience according to GMP in the (bio)pharmaceutical industry
- Proficiency in English (oral and written)
- Strong communication and organizational skills
- Analytical and pro-active attitude
- Valid work permit for the Netherlands
Preferred Qualifications
- Fluency in Dutch
Benefits
- Competitive salary
- Flexible working hours
- 25 days of vacation with option to purchase 7 additional days
- Travel allowance or full reimbursement via NS Business Card
- Pension scheme with 50% employer contribution
- 8.5% choice budget balance (including holiday pay and year-end bonus)
- Professional training and development opportunities
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Eurofins BioPharma Product Testing Leiden B.V. · Leiden
