Compliance Auditor

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. About Us

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600-strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We’ve built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.

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