Ethics & Compliance Business Unit Specialist jobs in Chicago, IL

Scope of Work : Oversee & coordinate assigned CAPA program to increase compliance. Overdue CAPAs should be at zero to complete project.

Provide support to management with insights, analyses and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification and mitigation, quality, process, productivity / efficiency improvement initiatives with the going of effective corrective actions that prevent reoccurrence.

Provide guidance, interpretation, support, training, and key input to development groups for consultation and interpretation of regulations, guidelines, corporate standards, and policies regarding CAPAs.

Oversee and participate in the documentation, reporting, and closure of compliance issues.Organize and deliver training to departments regarding proper handling of CAPAs.

Ensure the follow-up of findings to ensure that appropriate actions have been taken and have adequately resolved the issues identified.

Evaluate policies and procedures for compliance with applicable regulations / guidelines and provide recommendations to management for continuous process improvements.

Serve as author of Quality Assurance Standard Operating Procedures (SOPs) as assigned.3-5 years' experience with CAPA management and compliance activities in the pharmaceutical industry.

A strong understanding of FDA regulatory requirements, guidelines, and standards.Expertise in assessing compliance issues, identifying risks, and recommending effective corrective actions.

The role may involve encountering various compliance issues and challenges. Candidates should demonstrate strong problem-solving skills and the ability to identify root causes, develop solutions, and prevent reoccurrence.

Experience in organizing and delivering training sessions to departments on CAPA handling is beneficial. Candidates should also possess leadership qualities to effectively lead compliance initiatives and inspire teams to achieve objectives.

Proficiency in Microsoft Office Suite and experience with CAPA management software or other relevant tools.

Last updated : 2024-04-23