Quality Assurance Pharmacist – France

Created in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care.

We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial and human knowledge to improve the patient journey.

For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.

What we offer:

The Quality Assurance Pharmacist in the Quality team will be responsible for ensuring that manufacturing processes : 

• Participating in the maintenance of the subsidiary’s quality management system, covering applicable regulations and standards (Good Practices, ISO13485): deployment of global procedures in the local quality system, management of deviations / CAPA, qualification and monitoring of GxP service providers, internal and external audit, control of changes impacting the local quality system.
• Ensure compliance with Good Manufacturing / Distribution Practices within the subsidiary and by its external service providers: ensure that products are received, stored, handled, approved, distributed and transported in accordance with the requirements applicable to maintaining their quality, ensure batch tracking activities and coordinate activities in the event of crisis management.
• In collaboration with Medical Affairs, contribute to medical and scientific information  products, in liaison with the service provider: follow-up and coordination of activities entrusted to the partner, handling of other requests.
• Responsible for external audits and inspections by health authorities.