Description

Entreprise :

Our client is a growing pharmaceutical company.

Description du poste :

We are seeking a highly motivated QA Operations Specialist to join our client's team. This role is critical in ensuring quality standards are met in collaboration with manufacturing and distribution partners.

Key Responsibilities:

* Coordinate and oversee QA Operations activities with external manufacturing and distribution partners.
* Maintain accurate tracking and processing of the company's QA operations.
* Ensure thorough and compliant documentation of QA activities.
* Support the Responsible Person (RP) in managing GxP-related projects.

Main Tasks:

* Manage and resolve quality complaints.
* Handle change control processes with both partners and internal teams.
* Oversee and manage deviations from partners and intra-company processes.
* Prepare and verify documentation for product release and shipment.
* Ensure proper documentation, record-keeping, and archiving of quality records.
* Coordinate Quality Technical Agreements (QTAs) and assist in audit processes.
* Compile monthly Quality KPIs for management reporting.
* Assist in the development and implementation of GxP training programs.
* Contribute to the continuous improvement of the Quality Management System (QMS).
* Provide support for additional quality-related projects as needed.

Description du profil :

* Degree in Pharmacy, or a related Master's in pharmaceutical sciences (or equivalent).
* At least 3 years of experience in QA Operations within the pharmaceutical industry.
* Proven experience working with external partners and QA systems (a plus).
* Familiarity with biological drugs, sterile products, or vaccines is advantageous.
* Fluency in English, both written and spoken.
* Strong understanding of Good Manufacturing Practices (GMPs) and Good Distribution Practices (GDPs).
* Ability to work part-time across the entire week.