Quality Assurance Specialist M/F

Il y a 5 heures

Luxembourg Resonance Inside Temps plein

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.