Compliance Specialist in the Quality Solutions and Compliance Team

Thermo Fisher Scientific · Sofia

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Job Description

Join Us as a Compliance Specialist - Make an Impact at the Forefront of Innovation
The Compliance Specialist executes quality and compliance processes across the organization and facilitates the tracking and reporting of quality and compliance activities. The role involves maintaining tools and materials and providing expertise to advance the vision of the department.

What You'll Do:

• Research issues, track metrics, and maintain reports and documentation related to quality and compliance activities.
• Administer quality and compliance processes and ensure appropriate execution and completion.
• Contribute to projects and process/quality improvement initiatives.
• Communicate with representatives from other departments to ensure quality and timelines are maintained with respect to compliance activities (e.g., client audits, CAPA and/or procedural documents)
• Generate compliance metrics for Audits and Inspections teams
• Assist with the generation and distribution of trending reports
• Develop, validate and implement dashboards for Audits and Inspections teams
• Develop. validate and implement scorecards for Audits and Inspections teams as required
• Maintain conventions for Veeva data entry for Audits and Inspections
• Complete and document quarterly testing of Veeva Conventions, Dashboards etc.
• Manage the CDA process for Audits and Inspections teams
• Manage changes to Applications developed by the team
• Support the negotiation and implementation of Quality Agreements
• Support in the triage and review of Planned Deviations as assigned

Education & Experience Requirements:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills, Abilities:

• Excellent oral and written communication skills
• Solid organizational and time-management skills
• Firm knowledge of the clinical trial process
• Thorough knowledge and understanding of ICH GCP and other relevant regulations and guidelines

• Highly desired experience with VEEVA Quality Management System
• Effective problem solving skills
• Strong attention to detail
• Ability to work independently as required
• Strong computer skills; ability to learn and become proficient with appropriate software
• Ability to multitask and prioritize competing demands/work load
• Demonstrated flexibility and adaptability

Working Conditions and Environment:

• Work is performed in an office environment with exposure to electrical office equipment.
• Occasional drives to site/office locations with occasional travel both domestic and international

Why Join Us?
When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.
Apply today to help us deliver tomorrow’s breakthroughs.

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