Quality Systems Specialist
Maintain regulatory compliance and support quality systems in a pharmaceutical environment.
The role involves supporting senior management and qualified personnel in ensuring adherence to Good Manufacturing Practice (GMP), local, and corporate procedures, regulatory requirements, and industry standards. This includes reviewing and coordinating Corrective Action Preventative Action (CAPA) investigations, managing non-conforming products, and preparing information for presentation at Quality Review Board meetings.
* Support projects within the Quality Department to improve processes and maintain compliance.
* Review and coordinate CAPA investigations for deviations at the site that may impact product quality.
* Manage customer and supplier complaints, including investigations, reporting, and trending.
* Ensure management of the SAP disposition of non-conforming products.
Key Responsibilities:
* Developing and periodically updating quality procedures in conjunction with operational staff.
* Preparing information in advance for presentation at the Quality Review Board meetings.
* Assisting in the completion of internal audits of GMP systems.
* Managing stability data for the support of expiry dates.
Requirements:
* Bachelor's degree or higher in a related Science discipline.
* Demonstrated ability in quality systems support.
* Knowledge of EU quality-related pharmaceutical regulations.
* Experience in compounding and working in a manufacturing environment.