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Computerized System Validation Specialist, Netherlands - P

Employer
ClinChoice
Location
Netherlands
Salary
Competitive
Start date
31 Jul 2019
Closing date
30 Aug 2019

View more

Discipline
Manufacturing, Validation
Hours
Part Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)

Job Details

Description:
Title: Computerized Systems Validation Specialist

Location: Netherlands

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 Netherlands.

Purpose of the function:

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%


Skills: Quality Assurance Manager, Computer Systems Validation Location: Netherlands

Company

ClinChoice

ClinChoice is a recognized and highly respected mid-size, global, full-service contract research organization (CRO) specializing in clinical development, post-marketing, and functional service support. We provide comprehensive end-to-end solutions, taking products from early clinical development to post-approval lifecycle management. We are committed to fostering innovation in the pharmaceutical, biotechnology, medical device & diagnostics, consumer health, cosmetics, and nutraceuticals industries. Since our establishment in 1995, we have consistently delivered high-quality services and solutions throughout the entire development lifecycle of our clients’ products. We serve a wide-ranging clientele that encompasses six of the top ten pharmaceutical companies, leading medical device companies, preeminent biotechnology companies, the largest consumer health and cosmetics companies, and numerous small-to-mid-sized innovator companies. With over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are positioned to fulfil our clients’ needs locally and globally.

 

We’re on a mission to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices.

 

Company info
Website
Telephone
+44 1628 566121
Location
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom

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