Quality Specialist Role
This is a 4-month contracting position to support the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP).
* The successful candidate will assist in developing continuous improvement and compliance projects within the Quality Department.
Key Responsibilities:
* Maintain GMP, quality systems, local and corporate procedures, regulatory requirements, and industry standards.
* Review and coordinate CAPA investigations for deviations at the site impacting product quality.
* Coordinate customer and supplier complaints, including investigations, reporting, and trending.
* Define and update Quality Procedures in conjunction with operating staff while ensuring GMP and GDP compliance.
* Prepare information for presentation at Quality Review Board meetings.
* Assist in internal audits of GMP systems and complete corrective actions.
* Manage stability data for expiry date support.
* Support Pharmacovigilance and Compliance activities as required.
Requirements and Qualifications:
* 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 MIA environment.
* SAP experience.
* 3-5 years' experience in a pharmaceutical/regulated background with strong knowledge of compounding, GMP, and regulatory expectations.