We are seeking a Senior Expert in Digital Quality to join our team. This role is a key part of our dynamic environment, leading the way in innovation and digitalization within the industry.
The ideal candidate will be responsible for maintaining and enhancing the quality management system related to Computerized Systems Validation (CSV) and Data Integrity, ensuring that our site complies with Health Authorities' requirements and quality standards.
Key Responsibilities:
* Maintain and enhance the quality management system related to CSV and Data Integrity.
* Ensure compliance with Health Authorities' requirements and quality standards.
* Work closely with the Digital and Quality Assurance project teams to ensure quality specifications are met.
* Review and approve GxP documents, including User Requirement Specifications (URS), traceability matrices, risk assessments, drawings, procedures, and qualification and validation documents.
This is a unique opportunity to promote continuous improvement and drive innovative solutions in a supportive and collaborative environment.
We are looking for a passionate leader who can inspire a culture of quality excellence throughout our organization.
Requirements:
* Graduate degree with substantial to extensive professional experience in relevant fields.
* Senior knowledge and experience in quality assurance, quality management, IT compliance, or related areas.
* Proficiency and comprehensive knowledge of computer system validation (CSV) and Data Integrity requirements as defined by applicable health authorities and industry groups.
* In-depth understanding of quality management and CSV aspects related to computer system applications.
* Thorough knowledge of regulatory requirements.
* Strong attention to detail and excellent organizational skills.
* Autonomous, organized, and quality-driven with effective communication skills.
* Results-oriented with a strong focus on customer and quality.
We offer a competitive compensation package and opportunities for growth and development.