GCP Auditor

February 21

Apply Now

Receive Emails with Similar Jobs

eClinical Solutions

WebsiteLinkedInAll Job Openings

eClinical Solutions is a clinical data management company that provides integrated data review and management solutions for the biotech and pharmaceutical industries. Their platform, elluminate, empowers organizations to modernize and automate their clinical data workflows, ensuring efficient data acquisition, management, and analysis. By leveraging advanced analytics and technology-driven approaches, eClinical Solutions helps streamline trial operations and improve productivity, enabling better decision-making in clinical research.

Clinical Data Management • EDC Services • Statistical Programming • Clinical Data Reporting and Analytics • Clinical Data Repository Development and Management

201 - 500 employees

Founded 2012

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

💰 Private Equity Round on 2020-01

📋 Description

• You will make an impact: • As a GCP Auditor, you will play a key role in the Internal Audit and CAPA Management Programs and serve as the lead for Sponsor and Vendor Audit activities, quality metrics compilation, analysis, trending and reporting, and facilitation of, issues escalated to leadership, as well as Quality Improvement activities. • Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. • Your day to day: • Client Audit Hosting and Internal Audit activities, including follow up on the resulting actions • Complete Internal audit activities related to Delivery and Process audits • Ownership of managing the Quality Management System process gaps and needed improvements focused on the Services Organization which can be internally driven or a result of audit feedback • Work collaboratively across various functional organizations including India Operations • Inform senior management of any non-compliance incidents or regulatory compliance issues, which may arise internally or from external customers • Remain abreast of and apply updates to regulations, guidelines, and principles related to Good Clinical Practice and provide advice on their use and compliance • Work with company compliance experts by identifying quality issues and trends across various functional departments and establishing action plans for resolution • Assist in the review and approval of QMS procedures • Other duties as assigned

🎯 Requirements

• Bachelor’s degree or equivalent work experience preferred • 5+ years Pharmaceutical/Biotechnology industry or equivalent experience preferred • 3+ years of experience, ideally from a GCP Quality or Operational role within a Pharmaceutical, Biotech company or a CRO preferred • Certified Quality Auditor Certification or equivalent experience preferred • Experience drafting, editing, and reviewing GCP SOPs and WIs • Experience maintaining a QMS for the management of controlled documents, training, deviation, CAPA and audit management is a strong plus