Validation Consultant

This is a remote position.

We are looking for a skilled Validation Consultant to support the BIS eCompliance Team with activities related to Computer Systems Validation (CSV) and IT Quality Processes.

Must-have:

• Experience with management of Study Clinical Data
  
• Experience in SAS Life Science Analytics Framework (e.g. implementation and / or operation of SAS tools, as well as the creation of the related documentation)
  

Roles and responsibilities:

• Write the software validation deliverables and initiate review and approval document lifecycles in EDMS.
  
• Ensure the compliance with the methodology and SOP’s and ensure the use of relevant tools.
  
• Ensure that the project validation deliverables are complete and consistent and delivered on time.
  
• Ensure that project-related issues and deviations are recorded.
  
• Assist in writing, reviewing Validation SOPs and templates.
  
• Assist in resolving Computerized System Validation compliance issues.
  
• Create and manage quality events such as change controls, deviations, CAPAs, etc.
  
• Ensure timely, open, and effective communication to relevant stakeholders.
  
• Ensure project timelines are followed, and potential issues are communicated.
  

Requirements

• Experience in biopharmaceutical or development sciences, validation consulting for computer systems, understanding of global regulatory requirements, attention to detail, and ability to work autonomously.
  
• Preferable experience with clinical data management and SAS Life Science Analytics Framework.
  
• Master's degree in Bio-engineering, Chemistry, Pharmacy, or related fields.
  
• Proficiency in English and MS Office.
  
• Experience with Veeva software systems or similar (ERP, QMS) is an asset.
  

Benefits

• Remote work
  
• Food ticket
  
• Health insurance
  
• Training and access to certification vouchers
  
• Work-life balance initiatives
  
• Referral program
  
• Birthday off
  
• Give back day - enjoy a day to give back to society!