Job Overview
* Support the Quality Manager in ensuring adherence to Good Manufacturing Practice (GMP) for Medicinal Products, Quality Systems and regulatory requirements.
* Assist in the development of continuous improvement projects within the Quality Department.
* Review and coordinate CAPA investigations for deviations impacting product quality.
* Manage customer and supplier complaints - including investigations, reporting and trending.
* Define and update Quality Procedures with operating staff, ensuring compliance with GMP and GDP.
* Prepare information for presentation at Quality Review Board meetings.
* Conduct internal audits of GMP systems, assessing and verifying corrective actions.
* Maintain approved Specifications in Document Management and ensure distribution.
* Record, investigate and report incidents and deviations.
* Assess risks with Process Owners and assign counteractive measures.
* Document change controls through completion.
* Manage stability data for expiry dates.
* Coordinate product recalls and mock recalls.
* Support Pharmacovigilance and Compliance activities.
* Issue protocol and report numbers and maintain logs.
Requirements
* Bachelor's degree or higher; ideally in a Science discipline.
* Demonstrated ability in quality systems support.
* Knowledge of EU quality related pharmaceutical regulations.
* Experience in compounding and working in a MIA environment.
* Knowledge of Industry Best Practices for quality and compliance.
* SAP experience.
* 3-5 years' experience in a regulated background with knowledge of compounding, GMP and regulatory expectations.