Deviations Owner – GMP & CAPA Lead (Aseptic)

Mentor Technical Group; Juncosa; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Mentor Technical Group is seeking an experienced Deviation Manager to lead deviation investigations and CAPA in FDA-regulated environments. You will coordinate with production, QA/QC, and project teams, maintaining rigorous records and driving continuous improvement.

English proficiency is required and aseptic process experience is a must. The role involves supporting audits, optimizing deviation management processes, and ensuring regulatory compliance across multiple sites.

Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field.
• 5–10 years’ experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
• Experience in aseptic processes or sterile manufacturing environments is required.
• Strong understanding of GMP, FDA regulations, and quality systems.
• Proficiency in English; additional language skills are a plus.
• Experience with deviation tracking systems, CAPA management, and eQMS.
• Excellent analytical, organizational, and problem-solving skills.
• Strong communication skills and ability to collaborate across teams.

Responsibilities

• Serve as the primary owner for deviations, ensuring proper documentation, investigation, and resolution in compliance with FDA and internal quality standards.
• Coordinate with production, QA/QC, and project teams to evaluate deviations, determine root cause, and implement corrective and preventive actions (CAPA).
• Maintain accurate records of deviations, investigations, approvals, and follow-up activities.
• Monitor deviation trends and provide reports to management to support continuous improvement initiatives.
• Ensure timely communication of deviation status and regulatory impact to relevant stakeholders.
• Support audits and inspections by providing evidence of deviation management and compliance.
• Collaborate in the development and optimization of deviation management processes and SOPs.

Skills

Analytical thinking

Organizational skills

Problem-solving

Communication skills

Collaboration

Education

Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field

Tools

Deviation tracking systems

CAPA management

eQMS

GMP/FDA regulations knowledge

Job description

Mentor Technical Group is seeking an experienced Deviation Manager to lead deviation investigations and CAPA in FDA-regulated environments. You will coordinate with production, QA/QC, and project teams, maintaining rigorous records and driving continuous improvement.

English proficiency is required and aseptic process experience is a must. The role involves supporting audits, optimizing deviation management processes, and ensuring regulatory compliance across multiple sites.