Clinical Quality Assurance Auditor I/UtrechtDeze vacature staat offline! | ||
| De opdrachtgever | ||
|
CRO in provincie Utrecht | ||
| De omschrijving | ||
|
Primarily responsible for the continued maintenance of a CQA System at the Clinical Pharmacology Unit, the Netherlands with written Standard Operating Procedures (SOPs), to ensure that trials contracted to this company are conducted and the data are generated, recorded and reported in compliance with protocol, Standard Operating Procedures (SOPs), Project Plans, international requirements for Good Clinical Practice (GCP), e.g.; ICH-GCP, Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and other applicable (inter)national regulatory requirements. As part of the CQA Department, the auditor is responsible for, but not limited to: Providing guidance to Operations in their documentation and application of procedures; Supporting Operating Units (OU) and their quality control systems; Conducting periodic operational system and sponsor project specific data audits, vendor audits and regional office audits; Providing consultancy on quality and regulatory related issues. Conducts contracted audits, systems audits, regional office audits, for-cause audits and vendor audits Hosts Sponsor audits at the companies Assists senior CQA personnel in regulatory authority inspections Responds to and resolves issues relating to Sponsor audits and regulatory inspections performed under CQA management supervision Provides training to operations reviews or revises CQA SOPs Contacts immediately the Director, Global CQA if a regulatory agency has requested an inspection, or if there are any serious compliance observations Responds to Sponsor audits of sites external to this company, and resolve issues with Sponsor, where applicable Provide consultancy on quality / regulatory related issues for CQA functions Other duties as requested by CQA Management | ||
| De eisen | ||
|
Four year college degree (life sciences mandatory) with 2-4 years relevant clinical experience. Without a four year degree, minimal 4 years relevant clinical experience. Must have oral and written communication skills in English. Strong organizational skills and attention to detail; Strong communication and interpersonal skills; Computer literacy in MS Word, Excel, and PowerPoint; Professionalism. | ||
| Contactinformatie | ||
Heb je interesse in deze vacature, meld je direct aan middels de button 'aanmelden' of neem contact op met:
Geïnteresseerden kunnen hun c.v. ook rechtstreeks mailen naar andrea@pharmamediair.nl. |
