Quality Assurance Specialist

hace 2 meses

Lliçà d'Amunt, Barcelona, España Werfen A tiempo completo

About the Role

We are seeking a highly skilled Quality Assurance Specialist to join our team at Werfen. As a key member of our Quality Department, you will be responsible for ensuring that our internal and external audits are conducted in accordance with international regulations and standards.

Key Responsibilities

  • Conduct internal audits and participate in external ones to ensure compliance with regulatory requirements.
  • Develop and implement continuous improvement initiatives for our Quality System Management.
  • Plan, design, and manage our electronic document and record management system (EDRMS) to ensure GMP and ISO compliance.
  • Optimize our Change management system through the SAP change order module.
  • Ensure that all activities are performed in accordance with our Quality Management System.
  • Report metrics and provide guidance and monitoring to direct reports.
  • Lead internal follow-up meetings and train staff on new processes and improvements.

Requirements

  • Bachelor's degree in a related field.
  • Minimum 5 years of experience in a similar position.
  • Internal/External Audit expertise.
  • Software skills in Office Tools (Microsoft) and SAP.
  • Language proficiency in Spanish or Catalan and advanced knowledge of English.
  • Knowledge of Quality Regulations applicable to our company.

Skills and Capabilities

  • Agile decision-making under pressure.
  • Methodical and well-organized approach.
  • Teamwork and time management skills.
  • Ability to express information clearly and concisely.
  • Ability to apply a systematic approach and constant control.

Travel Requirements

  • 5-10% of travelling time.

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