Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or a related field.
5-10 years of experience in deviation management, quality assurance, or compliance in FDA-regulated environments.
Experience in aseptic processes or sterile manufacturing environments.
Strong understanding of GMP, FDA regulations, and quality systems.
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.
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.
Benefits
Opportunities for continuous professional development and training.
A collaborative environment with cross-departmental engagement.
Career advancement potential within a growing organization.
Full Job Description
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.
