Quality Assurance Specialist M/F
Il y a 5 heures
Luxembourg
Resonance Inside
Temps plein
Gratuit avec email ou Google
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Gratuit avec email ou Google
Job Offer Summary:
Mandatory Requirements:
- Formal qualification as a pharmacist issued by an EU Member State, eligible for recognition in Luxembourg under the applicable EU framework, including Directive 2005/36/EC.
- 8 to 15 years of experience in Quality Assurance within recognized pharmaceutical companies in a EU GDP and/or EU GMP-regulated environment related to medicinal products for human use.
- EU resident or holder of a valid Luxembourgish work permit.
Mission:
- Join the Quality Assurance team within a Luxembourg-based affiliate of the Pharmaceutical Group.
- Contribute to the effective oversight, maintenance, and continuous improvement of the company’s Quality Management System (QMS).
- Collaborate with various departments and stakeholders to support GDP governance and continuous improvement initiatives.
Main Responsibilities:
- Act as Responsible Person for GDP for one Luxembourg entity and as Deputy Responsible Person for another.
- Maintain effective GDP oversight, ensuring continuity and timely escalation of quality or compliance matters.
- Manage activities related to the governance, maintenance, and continuous improvement of the local QMS.
- Serve as a QA reference point for internal and external stakeholders.
- Manage quality processes related to product quality complaints, deviations, and follow-up actions.
- Participate in GMP and GDP audits and provide day-to-day QA support
Profile Sought:
- Excellent command of English, both written and spoken.
- Professional proficiency (minimum B2 level) in French
- Bé in German is a plus
- Proven experience in drafting and managing pharmaceutical quality agreements.
Behavioral Skills:
- Proactive, self-motivated, and solution-oriented.
- Collaborative team player with strong communication skills.
- Well-organized with excellent planning, prioritization, and time-management skills.
Expected Competencies:
- Quality Management, Quality Assurance, Pharmaceutical Operations, Quality Management Systems.
- Bilingual in English and French; German is a plus.