Pharma Compliance Auditor

Title :- Compliance Auditor

Location :- Bethlehem, PA (onsite) Fulltime

Summary

The Compliance Auditor's main function is compliance activities such as vendor management, customer audits, internal audits, regulatory support, prevent or eliminate deviations in procedures, and quality process improvement.

Essential Duties and Responsibilities

• Develop and coordinate the Internal Audit Program to ensure compliance to all relevant policies and procedures. This includes the issuance of audit reports and facilitation of timely closure of corrective actions by the respective departments.
• Perform audits, including focused and general audits of all GMP areas against cGMP standards and ensures resolution of any identified issues.
• Perform audits of suppliers/vendors in accordance with Sharp Clinical Services Vendor Audit schedule.
• Prepare report for internal and supplier audit findings in a timely manner to ensure compliance in accordance with SOP requirements.
• Host customer QA and qualification audits.
• Prepare responses to customer audit findings in a timely manner to ensure compliance in accordance with SOP requirements.
• Support regulatory and agency inspections, audits, investigations and inquiries regarding the control and assessment of product design and manufacturing quality.
• Responsible for maintenance and revision procedures related to the supplier and internal audit programs.
• Responsible for maintenance of the approved/qualified supplier listings and service provider listings.
• Generation of CAPAs related to audit findings.
• Develop Quality Agreements with vendors to establish quality standard for contracted services.
• Performs special projects and/or assignments as indicated by Quality Management.