PHARMACIEN(NE) ASSURANCE QUALITE (Industrie Pharmaceutique – CDMO)

The Pharmacien(ne) Assurance Qualité at EUROFINS CDMO is responsible for monitoring and ensuring compliance with Good Manufacturing Practices (BPF), managing the documentation quality system, conducting reviews of production files, and certifying drug lots. You’ll actively engage with operational teams to support quality initiatives and manage any quality-related events in line with ongoing projects.

To qualify for the Pharmacien(ne) Assurance Qualité role at EUROFINS CDMO, candidates must hold a Doctorate in Pharmacy and be registered with the relevant pharmacists’ order. A professional command of English and prior experience in Quality Assurance within the pharmaceutical or biotechnology industries are highly desirable.

EUROFINS CDMO promotes a collaborative work environment where the Pharmacien(ne) Assurance Qualité can autonomously manage daily tasks while contributing to cross-departmental projects with teams in both France and Belgium. The team's emphasis on constructive relationships with production services enhances collective performance and quality assurance processes.

Employees in the Pharmacien(ne) Assurance Qualité position at EUROFINS CDMO can look forward to a range of benefits including a flexible working schedule, 25 paid vacation days plus 12 RTT days, a company-sponsored meal allowance, free health insurance for employees and families, and financial incentive programs aimed at employee engagement.

The Pharmacien(ne) Assurance Qualité at EUROFINS CDMO plays a crucial role in preparing for and participating in client audits and regulatory inspections. They ensure that the quality systems in place are compliant with industry standards, contributing to a transparent and thorough inspection process for continued operational excellence.

When answering this question, focus on specific examples from your previous roles where you implemented or ensured compliance with Good Manufacturing Practices. Highlight challenges you faced and how you overcame them, showcasing your commitment to quality assurance.

Share your strategies for maintaining organized documentation and effective quality management systems. Discuss tools or methodologies you utilize, as well as your methods for ensuring compliance with regulatory requirements throughout the documentation process.

Discuss a systematic approach you would take to managing quality events, emphasizing your analytical skills. Explain how you would document the issue, investigate root causes, and implement corrective actions to prevent recurrence while engaging relevant stakeholders.

Explain the importance of collaboration and communication in your role as a Pharmacien(ne) Assurance Qualité. Discuss strategies for fostering positive relationships, such as regular meetings with production staff, joint training sessions on quality principles, and being available for real-time assistance.

Recognize that lot certification ensures product quality before distribution. Explain your understanding of the certification process, including reviewing all supporting documentation to confirm that the product meets required specifications, and its impact on patient safety and compliance.

Select a specific project where you were able to enhance quality processes. Describe your role, the challenges faced, the solutions you implemented, and the measurable outcomes that resulted, demonstrating your proactive approach to quality assurance.

Describe your methods for staying informed about changes in regulations and standards. This could include participating in industry webinars, joining professional organizations, and regularly reviewing industry publications and guidelines from health authorities.

Elaborate on your experience with supplier quality management, detailing any processes you have in place for assessing and monitoring supplier compliance with quality standards. Discuss how you handle any vendor-related quality issues.

Discuss your time management and organizational skills, explaining how you prioritize tasks effectively. Share strategies like utilizing checklists, maintaining open communication with your team, and taking breaks to manage stress during high-pressure periods.

Express your enthusiasm for working within a leading global company like EUROFINS CDMO. Highlight the company’s commitment to quality in biopharmaceutical services and your alignment with its mission, along with your eagerness to contribute your expertise to their success.