CDMO Site Head Quality Director- Madrid

  • Ciencias de la Salud
  • Madrid

Leading CDMO pharmaceutical Group

CDMO Site Head Quality Director-  (Madrid)

PROJECT DESCRIPTION

 Important international CDMO  pharmaceutical company, it seeks for its headquarters in Madrid a senior profile for the position of Quality Director. The plant is located on the outskirts of Madrid(Alcorcón)and is mainly dedicated to manufacturing to third parties, marketing solid and sterile products, marketing it with its own packaging, for any application linked to the pharmaceutical industry and agriculture. Location: Madrid Report to: BU Head Website Date: December 2020   Ensure that the products and services marketed by XXXXX (Pharmaceutical Plant Brand) are compliant, manufactured, controlled and distributed in accordance with the Correct Manufacturing Standards and the Quality Specifications established for each them by the Company and authorized by the relevant health authorities. Interlocutor with health authorities and customers. Representative of the ISO 13485 and ISO 9001 System Directorate. Comply with the guidelines set out in the company’s management and leadership policy.   Main functions: Techniques

  • Preparation, implementation and strict monitoring and compliance with the Company’s Quality policies.
  • Ensure the correct implementation and application of the quality management system, NCF, ISO 13.485/9001 and documentation management in the plant.
  • Ensure that customer requirements are promoted at all levels of the organization.
  • Ensure compliance with the working instructions described in the control procedures for manufacturing raw materials, packaging material, semi-finished products and finished products.
  • Ensure quality control of raw materials, conditioning materials, semi-finished and finished product. Control in process and stability.
  • Directly or by delegation, approval or rejection, as appropriate, of starting materials, packaging materials and intermediates, in bulk and finished.
  • Directly or by delegation evaluate the protocols of each batch.
  • Ensure that all necessary tests are performed.
  • Directly or by delegation approve specifications, sampling instructions, test methods and other quality control procedures.
  • Directly or by delegation, approve and control contract analyses
  • Check the maintenance of your department, premises and equipment.
  • Implement, develop and execute the Plant Validation Master Plan, which collects all validation activities, production processes, cleaning methods, analytical methods, transportation, etc.
  • Ensure that the necessary validations are performed.
  • Establish a quality system that ensures compliance for released batches.
  • Ensure batch release and certify compliance.
  • Estimate the actions that may affect the quality of products and services.
  • Ensure that information related to quality incidents is dealt with effectively.
  • Manage claims and reports of anomalies and non-conformities.
  • Directly or by delegation, approve the documentation related to Quality at the Plant level.
  • Ensure that the initial and continuous training required for your department staff is provided and that the training is tailored to your needs.
  • Ensure external communication of quality issues according to corporate and health policy directives.

  Shared with the Chief Operating Officer

  • Authorization of written procedures and other documents, including their modifications.
  • Monitoring and control of the environmental conditions of the manufacture.
  • Industrial Hygiene.
  • Process validation.
  • Training.
  • Approval and control of material suppliers.
  • Approval and control of subcontractors.
  • Designation and control of storage conditions for materials and products.
  • Protocol preservation.
  • Control of compliance with the Manufacturing Correct Standards.
  • Inspection, investigation and sampling in order to re-test factors that may affect the quality of the product.

  External  Affairs

  • To be the privileged partner and to monitor the inspections of health authorities and audits carried out by external bodies.
  • Coordinate and/or perform audits (subcontracted providers and services).
  • Check the preparation and transmission to health authorities of annual (psychotropic, narcotic stopephing…).
  • Ensure the plant’s participation in product recalls and pharmaceutical alerts of products manufactured by XXXXXX (the Company).
  • Develop the program of continuous improvement in Plant Quality (Quality Plans), within the framework of the Quality Directives and ensure its implementation in all areas.
  • Carry out the quality system review at least once a year and ensure its effectiveness.
  • Ensure regulatory compliance based on regulatory developments.
  • Regularly coordinate quality meetings at the plant level to raise people’s awareness and track projects.
  • Establish and verify the realization of corrective action plans linked to Quality incidents.
  • Identify and ensure compliance with individual and collective training programs in the area of Quality.

  GMPs

  • Ensure that all tasks in your area of responsibility comply with GMP, ISO and related Quality directives.

  HSE

  • Comply with and ensure compliance with the Safety, Hygiene and Environment standards established by current legislation and the Company’s rules in its area of responsibility.
  • Ensure the annual revalidation ISO 14.001 and OSHAS 18000 in your area of responsibility.

  Budget control

  • Study, realize and execute the budget of your Department in collaboration with the Finance Department and the Business Unit Directorate.
  • In collaboration with the Director of the Business Unit and the different areas of the plant, develop and control the Annual Investment Plan of the Quality area ensuring an optimal level of compliance in terms of resources, deadlines and costs.

  People management and leadership

  • Organize and coordinate the human team in order to obtain the best working climate, maximum efficiency and creativity of each and every member of the Quality department.
  • Carry out XXXXX’s HR policies. Hh. with your team (recruitment, introduction, training and development).
  • Develop your team’s training plan in collaboration with the Human Resources Department.
  • Motivate and develop your team’s staff according to the interests of the person and the needs of the company.
  • Distribute the work and organize your staff, ensuring the achievement of the results and compliance with the established standards.
  • Ensure the flow of information between employees in the Quality area and other departments by transmitting the policy and values of XXXXX.

  Replacement in case of absence: Responsible for Operational Quality Assurance. Responsible for Quality Assurance Systems.   Resources

  • Team in charge: 50 people Quality department staff
  • Budget: The department’s own.
  • Tools / Technology: Computer systems for position performance (SAP, Windows, Excel …).

    Other information  Optimaes Talent Please send cv to Carlos Jordan de Urries    Carlos@optimaes.es

Para solicitar este trabajo envía un correo electrónico con tus detalles a carlos@optimaes.es