Quality Assurance Specialist – GDP Responsible Person

High quality therapeutics and diagnostics solutions for patients, ethics as an underlying principle, dedication to innovation and advancement, strong people centricity and environmental sustainability. These five pillars form the foundation of our client, a pharmaceutical company with more than 135 years of history.

Job Description
THE ROLE We are seeking an experienced Quality Assurance Specialist to support the oversight and continuous improvement of a local Pharmaceutical Quality Management System (QMS). You will act as the GDP Responsible Person for one Luxembourg entity and as Deputy or Backup Responsible Person for another, in line with your formal appointments and applicable authorisations. Working closely with the existing Responsible Person and a range of internal and external stakeholders, you will help maintain effective GDP governance, inspection readiness and a strong quality culture. The role covers GDP
- and GMP-regulated activities involving medicinal products for human use, including licensing, contract manufacturing and distribution.

Key Responsibilities
• Carry out GDP Responsible Person duties for one entity and Deputy or Backup duties for another, as formally appointed.
• Maintain appropriate GDP oversight, ensure continuity of Responsible Person duties, and escalate quality or compliance matters when needed.
• Manage and improve the local QMS, including documentation, training, quality events, CAPAs, change control, metrics and inspection readiness.
• Support quality processes for product complaints, deviations and investigations, maintaining accurate records and follow-up actions.
• Draft, review and maintain quality and technical agreements with internal and external stakeholders.
• Review commercial agreements for alignment with quality standards and regulatory requirements.
• Provide day-to-day QA support to the business and act as a quality contact for affiliates, manufacturers, suppliers, customers and service providers.
• Support quality projects using a practical, risk-based approach.
• Participate, as appropriate, in GMP and GDP audits, supplier oversight and inspection preparation. Profile / Requirements REQUIRED QUALIFICATIONS AND EXPERIENCE
• A formal pharmacist qualification issued by an EU Member State, eligible for recognition in Luxembourg under the applicable EU framework, including Directive 2005/36/EC, Annex V, point 5.6.2.
• 8 to 15 years of Quality Assurance experience in a pharmaceutical company operating in an EU GDP
- and/or GMP-regulated environment for medicinal products for human use.
• Excellent written and spoken English, with the ability to communicate complex quality and regulatory topics clearly.
• Professional proficiency in French and/or German, at least B2 where required for authorisation to practise as a pharmacist in Luxembourg.
• EU residency or a valid Luxembourg work permit. Additional Experience And Skills
• Experience drafting and managing pharmaceutical quality agreements, technical agreements and quality-related commercial provisions.
• Sound knowledge of pharmaceutical QMS processes, including complaints, deviations, investigations, CAPA, change control, training, audits, metrics and supplier or customer oversight.
• Ability to interpret regulatory and corporate requirements and turn them into practical, compliant solutions.
• A proactive, reliable and well-organised approach, with strong planning and prioritisation skills.
• Clear communication and a collaborative working style across functions and cultures.
• A strong commitment to customer service, quality and regulatory compliance. This role offers broad exposure to international GDP and GMP activities and the opportunity to contribute to the ongoing development of a local Quality Management System. Benefits
• Excellente rémunération sur 13 mois
• Teleworking: may vary depending on place of residence
• Group health insurance
• Restaurant vouchers
• ... and more