Quality Assurance Auditor en PRA INTERNATIONAL ESPAÑA

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Quality Assurance Auditor
As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs.

At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace.

Our growing workforce is comprised of over 15,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages – yet operate in unison as one worldwide PRA community.
Baleares, Madrid, 23 Mar.
What will you be doing as Quality Assurance Auditor?

As QA Auditor, you will be dedicated to one of our global pharmaceutical clients, a company that values performance, recognises merit and has a high focus on quality. This environment encourages innovation, individuality and embraces people that want to be a part of it.

You will assist in the management of overall quality, compliance, and auditing activities to ensure compliance of operations with corporate policies, industry standards, and applicable regulations. This includes conducting a variety of audit activities which may include, but not be limited to. internal process audits, study specific audits (e.g.  internal and external investigator site, in process, trial master file, clinical study reports) and audits of vendors used to support company services. 

The QA auditor provides consultation, mentoring and compliance for the organization on GCP areas by ensuring quality activities are performed and documented in compliance with Standard Operating Procedures (SOPs), company guidelines, and applicable regulations. Besides this the QA Auditor:

 Performs contracted, routine and complex audits according to client expectations and/or PRA SOPs.
Plans and ensures audits are scheduled.
Conducts audits to identify non-conformities in adherence to protocols, SOPs, regulations, GCP, and expectations for data accuracy and completeness.
Reports observations/findings according to client SOPs and report templates.
Tracks, collects and reports responses and corrective actions per contract with client SOPs.

Numero de vacantes: 1
You are:

A dynamic and detailed oriented person.

Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:

Life science degree on Bachelor or Master level from an accredited institution
Read, write and speak fluent English and Spanish
Excellent verbal and written communication skills.
Excellent organizational skills.
Experience in a Quality Assurance Auditor role in clinical trials

Strong experience conducting GCP audits
Availability to travel across EMEA

Estudios mínimos
Sin estudios.
Experiencia mínima
2 años
Disponibilidad para viajar
El 40% del tiempo laboral

Esta oferta ha recibido 36 inscripciones.
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