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Excelya

Operational Quality Assurance Pharmacist

1w

Excelya

Meung-sur-Loire, FR · Full-time · €50,000 – €70,000

About this role

At Excelya, we combine passion for science with enthusiasm for teamwork to redefine excellence in healthcare. As Operational Quality Assurance Pharmacist, reporting to the site's Deputy Pharmacist, ensure the pharmaceutical facility's regulatory compliance per GMP/GCP and quality systems. Maintain quality of stored and distributed products while participating in equipment qualification and validation.

Your main tasks include implementing GMP and GLP compliance on site, applying company quality procedures, and ensuring validation processes for installed equipment. Monitor quality indicators through collection, preparation, and communication to the Quality Department. Ensure adherence to customer specifications and services, implementing necessary actions.

Prepare and conduct external audits of carriers and suppliers, and participate in customer and regulatory authority audits. Lead training initiatives for site employees on quality, GLP, GMP, and pharmacovigilance. Join a young, ambitious health company of 900 Excelyates driven to become Europe’s leading mid-size CRO.

Benefit from our one-stop provider service model offering full-service, functional service provider, and consulting for diverse projects. Work alongside preeminent experts to enhance scientific, operational, and human knowledge for the patient’s journey. Excelling with care nurtures your potential in an environment valuing natural talents and audacity.

Requirements

  • Doctor of Pharmacy (industry option), eligible to enroll in Section B
  • Ideally, Master's degree in Qualification/Validation/Quality/Industrial Processes and/or engineering school training
  • Rigorous and organized, able to work in a complex environment with internal and external clients
  • Good command of Microsoft Office, particularly Excel and PowerPoint
  • Good level of written and spoken English

Responsibilities

  • Ensure implementation of and compliance with GMP and GLP on site
  • Apply the company's quality procedures
  • Ensure compliance with validation and qualification procedures for site equipment
  • Monitor quality indicators through collection, preparation, and communication to the Quality Department
  • Ensure compliance with customer specifications and services, implementing necessary actions
  • Prepare, conduct, and follow up on external audits of carriers and suppliers
  • Prepare for and participate in audits by customers and regulatory authorities
  • Lead training initiatives for site employees on quality, GLP, GMP, and pharmacovigilance

Benefits

  • Europe’s leading mid-size CRO with the best employee experience
  • One-stop provider service model for full-service, functional service provider, and consulting
  • Evolve through diverse projects working alongside preeminent experts
  • Environment that values natural talents, pushes boundaries with audacity, and nurtures potential