Quality Assurance Auditor
Merial

General Summary: 

Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,000 people and operates in more than 150 countries worldwide. Its 2007 sales were nearly $2.5 billion. Merial Limited is a joint venture between Merck & Co., Inc. and sanofi-aventis. For more information, please see www.merial.com.

Essential Duties and Responsibilities

Reporting to the R&D Quality Assurance Director, the incumbent provides support to new product registrations in Merial. Implements procedures to ensure the integrity of all Merial research output intended for regulatory submission. The incumbent provides regulatory and quality guidance to research personnel. The incumbent works autonomously to resolve quality issues and audit findings Major responsibilities include the following: Audit assigned efficacy, safety, validation data and reports for compliance with US and EU regulatory directives (i.e., FDA, EPA, and OECD); Ensure that studies are conducted and the data collected in compliance with appropriate guidelines, protocol, Standard Operating Procedures and/or other governing factors; Assist in conducting audits of R&D departments for compliance with regulatory directives and corporate, divisional and departmental policies and procedures; Issue timely and accurate audit reports that communicate what was audited and any observations or non-compliance issues observed; Identify opportunities for quality improvements and assist in gaining approval for and implementing quality improvements Provide timely and accurate reporting of appropriate measures of quality performance; Review R&D departmental SOPs for compliance with regulatory directives and Merial quality standards; Conduct audits and inspections of Merial and contract facilities to ensure adherence to Merial quality requirement.