Capa Specialist

2 weeks ago

Bedford Park, United States Raland Compliance Partners Full time

**Job Description**:
Job ID#:
1591

Job Category:
Medical Device/Pharma/Biotech

Duration:
6 months
- 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.

Job Requirements

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