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
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 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.
- Website
- https://clinchoice.com/
- Telephone
- +44 1628 566121
- Location
-
Suite G48
268 Bath Road
Slough
Berkshire
SL1 4DX
United Kingdom
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