Quality Specialist
Job Description
We are currently recruiting for a Quality Specialist to work on a 4-month contract role. This is an excellent opportunity for a quality professional to join our team and contribute to the delivery of high-quality products.
The successful candidate will report to the Quality Manager and be responsible for supporting the development of continuous improvement and compliance projects within the Quality Department. Key responsibilities will include:
*Supporting the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
*Assisting the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department.
Responsibilities:
*Ensuring that the handling, order processing and approvals of patient scripts is completed as per the requirements of the Medical MIA.
*Reviewing and approving the Spanish patient scripts from Medical in Spain and updating the Patient ID log accordingly.
*Requesting the removal of stock from the quarantine block in SAP and for the verification step for Patient Specific TPN Orders prior to manufacture by Medical in Spain.
*Reviewing and coordinating any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied to Medical.
*Coordinating customer and supplier complaints - including investigations, reporting, and trending. Ensuring the management of the SAP disposition of non-conforming products.
Requirements:
*3-5 years experience in a pharmaceutical/regulated background with strong working knowledge of compounding, GMP and regulatory expectations.
*Bachelors degree or higher; ideally 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.
*Knowledge of Industry Best Practices for quality and compliance related topics.
*Ability to process technical information.
*Accuracy and excellent attention to detail are key attributes along with strong organisational skills.
*Strong verbal and written communication skills.
*A proactive and collaborative work style and the ability to work with multiple priorities and deadlines.
*Proven decision-making capability with accountability and responsibility.
*SAP experience.