Job Location: Mont-Saint-Guibert

Senior Windev Developer

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #13973

 

Senior Windev Developer

Job Description

  1. Support the CIP program for any development needs to support the improvement of our processes.
  2. Support Intergrations/Intefaces during but also after implementation. Keep system running in good conditions. Solve day-to-day queries and issues.

Main responsibilities

  • Support CIP program and CIP team to make any necessary development to transfer the required process changes into the CEMS system.
  • Interfaces / Integrations maintenance.
  • Solve any issues or day-to-day emergency problems in relation to these systems
  • Analysis, development, testing and documentation of ERP modules and web services.
  • Write new software, design graphical interfaces and write operating manuals.
  • Carry out software modelling and simulation.
  • Design test scripts and perform software testing and quality assurance.

Prerequisites

  • Bachelor or Master Degree IT oriented.
  • Experience of min. 10 years in software development preferably using WinDev/Webdev.

Skills

  • Experience in development of large applications using agile scrum methodology.
  • Be Object Oriented Programming Minded.
  • Document writing skills.
  • Knowledge and understanding of IT compliance matters.
  • Knowledge and understanding of ERP systems.
  • Knowledge of other web languages is an asset.
  • Stress resistant.
  • Team player.
  • Strong analytical skills.
  • Customer and Quality focus skills.
  • Make it happen mindset.
  • Knowledge of other web languages is an asset.
  • Stress resistant.
  • Team player.
  • Strong analytical skills.
  • Customer and Quality focus skills.
  • Make it happen mindset.

IT Compliance Consultant

  • Location: Mont-Saint-Guibert
  • Type: Contracting
  • Job #13972

 

 

IT Compliance Consultant

Position Purpose

The IT compliance consultant audits CCSM IT systems and software for compliance against GxP, US and EU regulations.

Key Tasks and Responsibilities

  • Update the inventory of IT systems and software and their interconnections
  • Check each system and the overall system for GxP compliance
  • Check each system and the overall system for EU and US regulations compliance
  • Propose and write the related quality events and Change Controls
  • Propose solutions for the recurrent and one shot qualification strategy for computerized systems
  • Write high-level data integrity assessments
  • Propose improvements to computerized systems SOPs & policies
  • Function as compliance matter expert to the IT Compliance Lead 
  • Know, understand and comply with the company’s standard operation procedures and policies

Qualifications and Experience

Experience

  • having worked in an IT-related Quality department in an international GxP environment for at least 5 years
  • able to apply GAMP5 “Risk based approach to compliant GxP computerized systems”

Hard skills

  • knowledge (above average) of EU GMP, cGMP and ICH
  • basic quality techniques (PDCA, 6M, 5 Why, Kaizen, Pareto, Ishikawa, …)
  • compliance knowledge
  • good understanding of software, data integrity and IT systems 
  • a certification in software audits is welcome

IT Compliance Officer

  • Location: Mont-Saint-Guibert
  • Type: Perm
  • Job #13970

 

IT Compliance Officer (Computer System Validation)

Position Purpose

The IT compliance lead coaches and drives improvement in the IT team from a quality and compliance perspective.

Key Tasks and Responsibilities

  • Propose and implement improvements related to IT compliance
  • Write and monitor the Deviation and the CC (Change Control) process
  • Support validation / qualification strategy for computerized systems and write periodic evaluation reports for computerized systems
  • Support quality risk management computerized systems
  • Write and monitor data integrity assessments
  • Perform proper management of IT SOPs & policies, write and review of procedures
  • Document review/approval and report generation, as requested
  • Function as Quality department liaison and compliance matter expert to other department representatives, customers and regulatory representatives
  • Monitor and notify changes in IT-related GxP regulations and propose improvements
  • Cultivate integrated working relationships with employees and other departments to maintain and foster quality standards
  • Contribute to the IT department's activities to ensure continuity of operations.
  • Know, understand and comply with the company’s standard operation procedures and policies

Qualifications and Experience

Experience

  • having worked in an IT-related Quality department in a GxP environment for at least 2 years
  • able to apply GAMP5 “Risk based approach to compliant GxP computerized systems”

Hard skills

  • knowledge (above average) of EU GMP, cGMP and ICH
  • basic quality techniques (PDCA, 6M, 5 Why, Kaizen, Pareto, Ishikawa, …)
  • compliance knowledge
  • good understanding of software, data integrity and IT systems