Our organization is committed to delivering innovative solutions that add value across various business functions. We are a global leader in the healthcare industry, dedicated to making life better for people around the world.
About this Role
This position requires the implementation, maintenance, and operations of quality systems for a Global Business Solutions Center. Key responsibilities include:
* Supporting our SOP system, including initiation, review, and approval;
* Managing GMP record retention;
* Supporting product quality personnel qualification activities;
* Managing the Deviation & Change Control system, including evaluations, close out, tracking, and trending;
* Proposing actions and managing the Quality Plan;
* Supporting the Quality Manual and Recall activities;
* Managing Product Complaints from receipt to final close out;
* Supporting projects with quality involvement;
* Product Quality instruction and training;
* Compliance activities, including supporting audits and self-assessments;
* Ensuring regulatory and quality impact reviews for deviations and Change Control;
* Supporting GMP compliance of SAP activities;
* Ensuring quality coverage for supply chain activities and interactions between service providers and affiliates;
* Managing inventory management systems, including expiration and retest monitoring, returns, destruction, and adjustment of inventories;
* Providing guidance on resolution of complex quality issues;
* Supporting quality management activities within SAP QM Power users and QM Data Steward activities;
* Supporting order overrides and DSP requests;
* Actively communicating with affiliate QA colleagues and responsible complaints personnel;
This role requires fluency in English, French, Dutch, and German and proficiency in MS Office, SAP, Trackwise, and One QMS. A degree in scientific disciplines such as Pharmacy, Chemistry, Biochemistry, or Microbiology is preferred. Previous experience in quality assurance, supplier quality, regulatory, medical information, laboratory, supply chain, or other quality-related roles is required.
We promote operational excellence through effective processes and collaboration. This role offers opportunities for professional growth and development.