CROMSOURCE

Computerized System Validation Specialist, Germany - L

Company
CROMSOURCE
Location
Germany, Aachen
Salary
Competitive
Posted
31 May 2019
Closes
30 Jun 2019
Ref
HQ00001853
Hours
Part Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
Description:
Title: Computerized Systems Validation Specialist

Location: Aachen, Germany

Schedule: Permanent/Full Time

Currently CROMSOURCE, a mid-sized international CRO, is looking for an experienced GXP Systems Validation Specialist to join our team in Germany.

The Computerized System Validation Specialist (CSVS) ensures that CROMSOURCE complies with applicable regulatory requirements and industry standards relating to hardware qualification and software validation and controls.

Responsibilities:
  • Edits the Validation Plan in compliance to applicable regulatory requirements and Company procedures
  • Supervises the management of Validation Plan activities
  • Performs a quality control, assuring that all the required validation documents meet all internal and external regulations/procedures to support the product release
  • Acts as a Project Manager for the internal Information Technology projects (e,g. software application) if needed.
  • Supports and guides the Computerized System Validation Associate (CSVA)
  • Performs the periodic review to the validation process in cooperation with the Quality System Manager (QSM)
  • Performs the Computerized System Validation training to all Company personnel


Job requirements:

  • University Degree in scientific disciplines
  • Three (3) years (at least) of experience in clinical research field
  • Two (2) years (at least) of experience in Computer System Validation (Clinical software service provider-eCRF, eTMF, CTMS, LIMS, ERP, ePRO, IRT, SharePoint, etc)
  • Advanced English knowledge
  • Strong knowledge of ICH-GCP/ Knowledge of software programming; performing/hosting audits
  • Strong knowledge of GAMP, FDA (e.g. 21CFR part 11; Guidance for Industry), ICH, ACDM/PSI Guidelines
  • Basic IT knowledge, expert in software development life cycle applied to GxP field; knowledge of the following software categories: ERP, IRT, CTMS, document management systems (e.g. SharePoint), eTMF, eCRF, LIMS, Microsoft office suite
  • Proficiency in Microsoft Office (e.g. Word, Excel, Outlook)
  • Willingness to travel (domestic and international)-up to 50%


If you have the experience needed for this position, please apply directly to: https://www.cromsource.com/careers-test/job-vacancies/job-information/?job-id=Hq00001849

If you would like to discuss the role before applying through the website, please contact mailto:holly.price@cromsource.com holly.price@cromsource.com for more information.

Why CROMSOURCE?

CROMSOURCE is an independent, international Contract Research Organization (CRO) operating in over 40 Countries and 16 offices with approximately 500 professional team members, making it one of the largest independent CROs in Europe. Our international headquarters located in Verona, Italy and Waltham, USA and with local offices in Belgium, The Netherlands, Germany, Poland, Russia, Spain, Switzerland and the United Kingdom.

Our key approach is to equally value our clients and our own people. Our employees are the most valuable company asset and because we want to retain our staff, we ensure they work in a friendly environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel through our dedicated training team, focused on employee development. We also understand the importance of a good work-life balance and we offer flexible solutions for a high number of positions.

The success of these core values are evidenced by our below industry average turnover rates.

By joining our teams, you can be part of making a difference in the lives of people and experience a fulfilling and rewarding career. Together, we help our clients succeed in their work developing medicines and medical devices for patients around the world.

CROMSOURCE is an equal opportunity employer. All qualified applicants will receive consideration for employment in relation to race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran or military status or any other legally protected status. CROMSOURCE is also committed to compliance with all fair employment practices regarding citizenship and immigration status.

How can we help you on your next career move? Learn more on LinkedIn, Pharmiweb, Facebook, Twitter, and Glassdoor.

Key words: GXP, Clinical Systems Validation, Systems Audit, eTMF, ePRO, CTMS

Skills: Quality Assurance Specialist, Computer Systems Validation Location: Germany, Aachen