Compliance auditor Jobs in Indianapolis, IN

job summary : Responsibilities :

• Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)
• Contributes to global QA policies on interpretation / application of regulations
• Provide subject matter expertise to projects Support team in CAPA plan creation
• Hosts external audits / inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses
• Supports the QA–to-QA relationship with key client(s)
• Delivery of training in performance of audits (basic, intermediate, complex)
• Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and / or efficiency of the QA organization
• Supports the reporting of quality metrics and implementation of necessary corrective actions and / or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)
• Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed
• Other duties as assigned by management.

Skills : Compliance, Quality Assurance, Regulatory Compliance - Other Experience : Experienced6 year(s)

responsibilities :

Conduct work as identified on the audit activity table (listing on table is not all inclusive but a representative sample)

Contributes to global QA policies on interpretation / application of regulations

Provide subject matter expertise to projects Support team in CAPA plan creation

Hosts external audits / inspections e.g. regulatory inspections, strategic clients. Assists with the facilitation of audit responses

Supports the QA–to-QA relationship with key client(s)

Delivery of training in performance of audits (basic, intermediate, complex)

Participate (for multi-regulatory topics in area of expertise) global Quality initiative(s) aimed at improving compliance and / or efficiency of the QA organization

Supports the reporting of quality metrics and implementation of necessary corrective actions and / or process improvements via appropriate forum (e.g. Monthly Reports, Site Quality Review, Liaison meetings)

Ensure Regulatory Compliance and Quality Assurance (RC&QA) responsibilities, as indicated in applicable controlled documents, are followed

Other duties as assigned by management.

qualifications : Experience

Experienced

6 years

Education

Bachelors (required)

skills :

Compliance

Quality Assurance

Regulatory Compliance - Other