Pharmaceutical Quality Assurance Expert (M/F)

Join Amarylys, an outsourcing and recruitment consulting firm dedicated to the demanding world of healthcare. Born from the recognized expertise of ATESSIA in the fields of regulatory affairs, quality, and pharmacovigilance, our Paris-based firm embodies excellence in supporting talent and realizing growth projects. With a human and personalized approach, Amarylys offers a unique career opportunity to passionate professionals eager to join dynamic teams and fully exploit their potential.

Our Muses, selected for their expertise and commitment, are the beating heart of our success. Together, let's make your skills shine in service of the healthcare industry. Discover a career where your ambitions meet our values: professionalism, agility, curiosity, soft skills, efficiency.

Explore Amarylys, where your future takes shape.

The position:

Amarylys is looking for a Senior Quality Assurance Expert M/F for one of its clients. Are you looking for professional experience in the pharmaceutical industry, within an international environment? Then apply now!

You will take charge of the operational management and continuous improvement of the site's quality activities. As such, your main responsibilities will be as follows:

• Lead the entire CAPA process: opening, investigations, root cause analysis, action follow-up, and closure.
• Ensure Change Controls management: chairing committees, coordinating stakeholders, validating actions, and reporting in the quality tool.
• Manage deviations: conducting investigations, monitoring quality indicators, and implementing corrective actions.
• Supervise the processing of customer and supplier complaints, including reporting to competent authorities when necessary.
• Take charge of the complete execution of Product Quality Reviews (PQR).
• Plan and conduct internal audits.
• Ensure the maintenance of the quality documentation system.
• Deploy and monitor the annual quality training program.
• Actively participate in the strategic projects of the Quality department.
• Deployment and optimization of the complaint management process in the quality tool.
• Structuring and continuous improvement of the complaint processing process.
• Contribution to the digitalization and performance of quality activities.

The list of missions is non-exhaustive. If you would like to know more, send us your application :)

Terms

• Start date: as soon as possible
• Duration: 10 months
• Location: Paris
• Contract: independent

Profile sought:

To succeed in this position, you must possess the following qualifications:

• Higher scientific education (Pharmacy, Master in Quality, Engineer, or equivalent).
• Significant experience in Quality Assurance within the pharmaceutical industry, in similar activities.
• Solid mastery of GMP/BPF standards.
• Knowledge of Product Quality Reviews (PQR).
• Experience in team management or coordination.
• Very good level of professional English, both written and spoken.