Site Quality Lead

hace 7 días


Madrid Centro, Madrid, España PMFarma A tiempo completo

Assures all pharmaceutical products conform to existing quality requirements, standard operating procedures, and government regulations and adheres to all good manufacturing practices.

Detalles del cliente

Multinational Pharmaceutical Company.

Descripción de la oferta

  • Develops the tactical and operational plans for the quality services department and ensures that tactical objectives are met in support of strategic targets.
  • Define Quality Strategy/Policy and make sure it is applied across all the Manufacturing Operations (Production, Reception, QA/QC, Engineering, Maintenance, Supply Chain).
  • Fix Quality & Compliance targets (Quality Plan).
  • Define organization and Quality & Compliance Systems / Processes (Quality Manual).
  • Define and follow: Budget, Performance Indicators, Evaluation/Development of collaborators.
  • Supervise Quality Control and Quality Assurance operations, ensure Release/Refuse batches conformity to rules.
  • Carry out periodical reviews of Quality Management (MQR) and make preventive and corrective actions the priority.
  • Give recommendations and interpretations for the respecting Conformity to cGMP.
  • Develop a strategy for attaining and keeping a permanent stare of respect to "365 cGMP ready" in accordance with a Risk based approach and Responsibility (Ownership) culture.
  • Develop and deploy in a continuous manner an intellect and attitude in accordance with Quality concepts and compliance.
  • Assure the conformity of batches of Finished good in view to their release, according to cGMP and specifications of the Marketing Authorization file (for pharmaceutical products, in the meaning of supporting the Qualified Person of the site).

QUALITY ASSURANCE OPERATIONS:

  • Regulatory evaluating Compliance cGMP and reporting to local and international management the status of the site's level of compliance.
  • Establishing tendencies in terms of Quality & Compliance, performance indicators and analyzing the root causes toward solving problems.
  • Reporting regulatory and systematically the Quality Indicators.
  • Offering support and recommendations for setting up new regulatory requirements and their up-dating.
  • Offering Technical and Scientific support to Operational Departments (QA/QC, Production, Validation, Engineering) in the context of complex investigations.
  • Assuring continuous attention to regulatory.
  • Creating a status of Inspection Readiness on the site of Madrid.

HUMAN RESOURCES:

Take part in recruitment (evaluation in terms of Quality & Compliance) and in the training and coaching of new employees.

Lead and manage the QA, QS and QC teams, establish individual and common objectives, monitoring and evaluation.

Leads cross functional teams and provides subject matter expertise to other departments.

Perfil del candidato

  • Bachelor degree in Chemistry, Pharmacy or Biology.
  • At least 5 years of experience in a Pharmaceutical environment in Quality positions. Master the cGMP rules issued by the European Community.
  • Robust knowledge of pharmaceutical industry processes and operations.
  • Robust knowledge of current regulations.

Oferta de empleo

  • A competitive salary package.
  • Comprehensive benefits package.
  • A collaborative and supportive work environment
  • Opportunities for professional growth and development.

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