Quality Unit Manager

We are a Spanish pharmaceutical company engaged in the research and development, manufacturing and marketing of small molecules and biological medical products.

We likewise use our sales channels to market a number of licensed pharmaceutical products, imaging contrast agents and other products for hospital use, as well as OTC pharmaceuticals.

All of this is carried out through our specialized sales team formed by more than 260 people who promote the products with specialized medical professionals and in hospitals and pharmacies.

· Lead, promote, and implement a Quality System, aligned with the requirements established in EU-GMP, US-GMP (21 CFR parts 4, 11, 210, 211, 820 chapters that apply) and other regulations applicable to the products affecting the plant, in compliance with the established corporate quality procedures.

Ensure the implementation and maintenance of a plant quality system based on the aforementioned standards.

· Functions and responsibilities established by Law for the Technical Direction.

· Ensure compliance with Data Integrity regulations, establishing plans, policies, and actions that favor compliance with said regulations.

· Provide support and ensure the application within the Quality area of the standards requested for the area in order to comply with the application of the standards.

· Stay up to date on new regulatory and GMP requirements.

· Disseminate a culture of quality. Ensure that training and capacity-building plans are established for all personnel involved in GMP activities. Ensure compliance with training plans in each of the areas. Direct the training, capacity building, and professional development of the personnel under their charge.

· Guarantee that the products manufactured in the plant are manufactured, controlled, handled, stored, and shipped to customers in compliance with the planned procedures and in accordance with the authorized specifications.

· Ensure periodic quality reviews of products and establish corrective measures in the event of needs for change due to quality problems. Ensure that investigations affecting the area are investigated on time and that the necessary CAPAs are established, if applicable.

· Set objectives and support their achievement. Monitor the established metrics and establish plans to correct any deviations that occur. Establish the quality objectives for their area of responsibility aligned with the plant/group objectives.

· Establish the budget for expenses, investments, and personnel for the quality area with their superior. Monitor its compliance.

· Develop functions, establish responsibilities, organize resources, and coordinate the activities of the personnel under their charge to comply with the quality objectives and requirements of the established quality system.

· Prepare for and defend Agency inspections and Client Audits. Establish a system of internal audits and audits of material and service providers that guarantee the suitability of products and/or services provided by the plant. Provide timely responses and follow up on the action plans established (CAPA) so that they are implemented on the planned dates.

• Periodically report the evolution of plant quality processes to senior management; escalate quality problems and risks for the product in a timely manner, as well as establish measures for their correction.

· Ensure an effective relationship with customers (quality assurance agreements) to align their requirements with GMP standards and plant processes. Ensure that Quality processes are executed attending to the needs of external and internal customers, in the required time and at an economic cost.

· Guarantee that the equipment, facilities, and auxiliary systems used in manufacturing and control operations are validated, qualified for use, and periodically maintained and/or calibrated.

· Provide support to the Development and Registrations areas in order to provide the necessary resources for the introduction of new products in the plant and the management of documentation requested for the preparation of registration dossiers.

· Coordinate the management of changes, complaints, or other investigations and risk analyses. Ensure compliance with plans, validation actions, preparation of documentation, etc., associated with change management before its implementation.

· Lead improvement projects for the area and collaborate on those for the rest of the plant, ensuring compliance with regulations and the company's internal policies.

Permanent