Job Description
The role will report to the Quality Manager and involve supporting them in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
As a key member of the Quality Team, you will provide critical support to the Quality Manager in ensuring adherence to regulatory requirements and industry standards.
* Support the Quality Manager and Qualified Person in maintaining compliance with GMP, for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
* Assist the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department.
* Review and approve Spanish patient scripts from Medical in Spain and update the Patient ID log accordingly.
* Request 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.
* Review and coordinate any CAPA investigations for deviations at the Spanish site which may impact on product quality for products supplied to Medical.
* Coordinate customer and supplier complaints - including investigations, reporting, and trending.
Key Responsibilities:
* Maintaining compliance with regulatory requirements and industry standards
* Developing and implementing quality systems and processes
* Ensuring accurate and timely completion of tasks and projects
* Providing excellent communication and collaboration skills
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.