Computer System Compliance Auditor - England, United Kingdom - ADAMAS Consulting

Description

ADAMAS is a well-established, leading provider of mission-critical regulatory compliance and consulting services to the global pharmaceutical industry.

It operates across Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Computer Systems Compliance (CSC) (together, GxP).

Founded in 2007, ADAMAS has focused on ensuring that the highest standards of best practice are attained across the pharmaceutical sector.

ADAMAS has an established client base with an expansive global reach, including North America, Europe, and Asia Pacific.

We work with over 100 currently active clients and have worked with over 700 pharmaceutical companies, including 40 of the 50 largest global pharma and biotech companies.

Job DescriptionPlanning, preparation, conduct, reporting and follow up of various types of audits according to expected quality and timelines Executing audits based on a comprehensive understanding of all regulatory requirements.

Performing quality assurance projects on behalf of client companies within the pharmaceutical/biotechnology industry.

Assisting with business development activities QualificationsBSc in Life Science preferred Experience in conducting and leading internal and external Computer System Compliance audits for a variety of stakeholders Experience in conducting a range of service provider audits (e.g., computer system validation audits, computer system compliance audits) Experience in conducting CSC/CSV systems audits.

Experience in coordinating and managing inspection preparation activities om support of regulatory inspections both at the sponsor and CRO. Expert knowledge of national and international computer system legislation and guidelines Up to 40% travel and ability to conduct remote audits