• Plans and independently conducts internal and external audits of GxP computer systems to ensure compliance and data integrity.
• Applies knowledge of applicable reguGxP lations/guidelines to assure adherence

to company, industry, and government standards and expectations.
• Prepares audit reports, evaluates and tracks responses, and measures effectiveness of associated CAPA.
• Keeps informed about current good industry practices and suggests areas of improvement.
• Performs general GxP compliance audit activities as needed.
• Consistently demonstrate QUALITY culture and behaviors and perform all duties in accordance with Luitpold and Daiichi Sankyo Business Principles, corporate directives, SOPs, policies, and government and industry regulatory guidelines.
• Support the Company’s Equal Employment Opportunity Policy as it applies to all the terms and conditions of employment, assist in the day to day implementation of the company’s current Affirmative Action Plan; including, but not limited to assisting with meeting “utilization" placement rate goals, reviewing and addressing allegations of discrimination, and maintaining a positive work environment that , “manages the difference."
• Perform any other tasks/duties as assigned by management.