CAPA Engineer

CAPA Quality Engineer, API Pharmaceuticals, Consultant

Summary

Our client, a Food Ingredient Provider, has engaged GForce Life Sciences to provide a CAPA Quality Engineer. This position will report to the Manager of Quality Assurance. The primary responsibility of the CAPA Quality Engineer is to oversee the implementation of corrective and preventive actions driving currently overdue items to zero and creating a system for maintaining that important key process indicator (KPI) of no overdue CAPAs.

Job Duties

• Oversee & coordinate assigned CAPA program to increase compliance. Overdue CAPAs should be at zero to complete project.

• Provide support to management with insights, analysis 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.

Mandatory Requirements

• 3-5 years' experience with CAPA management and compliance activities in the pharmaceutical industry

• 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.

• Experience working with Active Pharmaceutical Ingredients (APIs)

Term & Start

· 6+ month contract with a strong possibility of extension

· Start - June/July 2024

· 4-5 days a week onsite in Chicago, Illinois

· Benefits included (Medical, Dental, Vision, 401k)