Deviations Owner

Mentor Technical Group; Juncosa; In loco; EUR 65.000 - 90.000; Tempo pieno

Vantaggi offerti da questo lavoro

Equal opportunity employer

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical thinking

Organizational skills

Problem-solving

Communication skills

Collaboration

Formazione

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

Strumenti

Deviation tracking systems

CAPA management

eQMS

GMP/FDA regulations knowledge

Descrizione del lavoro

Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical, biotechnology, and medical device safety and efficacy guidelines. With offices in Caguas, Puerto Rico, and Boston, United States, we serve life sciences clients in six global markets: United States, Puerto Rico, Dominican Republic, Mexico, Germany, Canada, and South America.

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.

Qualifications / Requirements / Knowledge / Education / Skills:

• Bachelor’s degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field.
• Minimum of 5–10 years’ experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
• Previous experience working 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 electronic quality management systems (eQMS).
• Excellent analytical, organizational, and problem-solving skills.
• Strong communication skills and ability to collaborate effectively across teams.

Mentor Technical Group es un empleador que ofrece igualdad de oportunidades y todos los solicitantes calificados recibirán consideración para el empleo sin importar raza, color, religión, sexo, orientación sexual, identidad de género, información genética, origen nacional, estado de veterano protegido, estado de discapacidad o cualquier otro grupo protegido por ley.

_ Mentor Technical Group is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law. _