QA Systems Manager - Madrid, España - Barrington James

Barrington James

Empresa verificada

Madrid, España

hace 3 semanas

Publicado por:

Isabel García

beBee Recruiter

Madrid, Spain

Responsibilities:

Approve plant validations and qualifications to ensure compliance with regulatory requirements.
Conduct validation of computer systems (CSV) and assess the impact of incidents on GMP.
Monitor and oversee the performance of the plant, ensuring adherence to quality standards.
Lead the development and maintenance of the plant's documentation and training system, including personnel qualification kits.
Implement and manage the plants Data Integrity program to ensure data accuracy and compliance.
Coordinate and oversee area projects related to quality assurance and process improvements.
Manage the qualification process of AIT (Automated Inspection Technology) suppliers for the plant.
Participate in the plant audit program to assess and improve quality and compliance.
Contribute to aseptic validations of processes and provide oversight of plant operations.

Required Knowledge and Skills:

Minimum 2 years of experience in a tailings plant, including supervisory roles in Quality or Validations.
Expertise in computer system validation (CSV) to ensure system compliance and data integrity.
Knowledge of aseptic processes and their validation requirements.
Proficiency in validation principles and practices.
Strong understanding of GMP (Good Manufacturing Practices), particularly Annex 1, Annex 15, and Data Integrity guidelines.
Experience in risk analysis and ensuring data integrity throughout processes.
Excellent command of professional English, with strong communication skills to interact with internal and external stakeholders.
Flexibility, proactivity, and the ability to make informed decisions.
Good interpersonal skills to effectively communicate with clients and colleagues.

If you meet the above requirements and are seeking a challenging role in a dynamic environment, we encourage you to.

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