Company: inVentiv Health Clinical
Closing Date: 31 Oct 16
Salary (£): Negotiable
inVentiv Health – Transforming Promising Ideas into Commercial RealityJob Title:12689 Principal Auditor, EuropePrimary Function:This is an excellent opportunity for an experienced GCP Auditor who is looking for career progression. As a prominent addition to our Global Quality Assurance and Regulatory Compliance team you will be a key contributor in ensuring inVentiv as well as its vendors and third parties are in compliance with industry regulatory requirements and internal SOPs. ...
inVentiv Health – Transforming Promising Ideas into Commercial Reality
12689 Principal Auditor, Europe
This is an excellent opportunity for an experienced GCP Auditor who is looking for career progression. As a prominent addition to our Global Quality Assurance and Regulatory Compliance team you will be a key contributor in ensuring inVentiv as well as its vendors and third parties are in compliance with industry regulatory requirements and internal SOPs. The position offers flexibility to be home or office based in any of our European locations.
* Conduct and report audits, maintain records and disseminates issues from it
* Read and understand company SOPs and Operating Guides and audit compliance to same
* Facilitate client audits and regulatory inspections
* Prepare audit reports
* Follow up to resolution of Corrective and Preventive Actions
* Maintain audit status up to date in relevant system/tracker
* Perform role of Quality Representative to Operations as needed
* Assist with training and mentoring of less experienced Quality staff
* Conduct peer reviews of audit reports and/or QC of peer reviews
* Conduct For-Cause investigations
* Assist in Root Cause Analysis facilitation as assigned
* Assist with management of the Serious Quality Issues process as assigned
* Helps develop key quality indicators and analyses data and facts to identify and solve problems
* Act as QARC representative to clients, program and project teams
* Bachelor’s degree
* Proven relevant audit experience in Clinical Research
* Excellent communication, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade
* Ability to travel as necessary (approximately 30%)
In return we will offer:
* A competitive remuneration package with excellent benefits
* A commitment to your professional development as a key member of our Senior Leadership Team
* The opportunity to work within a successful and rewarding environment.
Location: EMEA, home or office based
We look forward to receiving your application.
inVentiv Health is a global professional services organization designed to help the biopharmaceutical industry deliver new drugs and therapies to market. Our combined Clinical Research Organization (CRO) and Contract Commercial Organization (CCO) is made up of more than 14,000 employees who have the ability to service clients in more than 90 countries. We offer a differentiated set of solutions designed to improve client performance and accelerate the process of bringing products to market. For more information, visit inVentivHealth.com
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