Talent.com
Validation Specialist
Validation SpecialistOPTEL • Québec, QC, Canada
Validation Specialist

Validation Specialist

OPTEL • Québec, QC, Canada
30+ days ago
Job type
  • Full-time
Job description
OPTEL is one of the world’s leading providers of traceability systems. Its mission is to leverage innovative technologies to create a better world through responsible capitalism. The company’s renowned solutions ensure the quality of healthcare products and help fight the counterfeiting of medicines and medical devices worldwide. OPTEL also adapts its technologies to a variety of sectors, from healthcare to smart manufacturing and beyond, enabling all industries to benefit from global traceability. OPTEL’s expertise empowers industries to measure, inspect, control, and track a wide range of elements in order to improve product quality and promote a more responsible use of resources.

Summary:
The Validation Specialist is responsible for creating and maintaining validation documents, such as internal validation protocols, Installation Qualification (IQ), Operational Qualification (OQ), and Change Controls, to ensure that Optel systems comply with industry standards. This role requires expertise in documentation, a drive for innovation through continuous improvement, and the ability to collaborate with internal teams and clients to ensure project validation and quality control.

Principal tasks:

Validation documentation and management:

  • Manage the validation template lifecycle: maintain, optimize, and automate existing templates (using MS Office Suite and VBA macros) to increase efficiency while ensuring regulatory compliance, such as Good Automated Manufacturing Practice (GAMP), FDA 21 CFR Part 11, and EU Annex 11.
  • Identify and implement continuous improvement opportunities, including leveraging Artificial Intelligence tools to streamline document drafting and review processes.
  • Review and understand system updates, including new releases and hotfixes, to determine the impact on validation documents.
  • Generate validation documents for clients based on the functional and design specifications of the projects.
  • Execute internal validation protocols as needed to ensure system functionality.

Risk Analysis and Quality Improvement:

  • Identify potential risks associated with validation activities and develop mitigation strategies.
  • Lead root cause investigations for validation discrepancies and implement corrective actions for continuous quality improvement

Collaboration and Expertise:

  • Partner with various internal departments to deliver validation documentation at specific stages of project development.
  • Collaborate closely with the internal team and clients to provide expert guidance on validation strategies and best practices.
  • Work closely with the quality assurance (QA) team to ensure that validation activities are in line with internal quality systems and external regulatory requirements by participating in internal and external audits.
  • Perform any other tasks related to validation processes.

Requisite Skills:
  • College diploma in a relevant field.
  • Minimum of 2 years of experience in system testing and validation or in technical writing.
  • Excellent proficiency in English (written and spoken).
  • Advanced knowledge of the Microsoft Office suite (World).
  • Knowledge of macros (Visual Basic / VBA) in Word and Excel is considered an asset.
  • Strong interest and aptitude for adopting new technologies, including the practical application of artificial intelligence for task optimization.
  • Rigor, analytical skills, and attention to detail.
  • Ability to collaborate effectively within a team and communicate with stakeholders at all levels.
  • Strong curiosity and a willingness to learn and adopt new technologies, especially artificial intelligence.

Benefits:
  • Competitive compensation
  • Flexible working hours
  • Employee Assistance Program (EAP)
  • Comprehensive group insurance plan
  • A global organization with a presence on several continents

OPTEL is an equal opportunity employer. We believe that diversity is essential to fostering innovation and creativity. We welcome and encourage applications from individuals of all backgrounds, cultures, gender identities, sexual orientations, abilities, ages, and beliefs. We are committed to providing a fair and inclusive recruitment process in which every candidate is evaluated solely on their qualifications, skills, and potential. At OPTEL, each employee’s unique perspective contributes to our collective success, and we celebrate the richness that diversity brings to our tea
Create a job alert for this search

Validation Specialist • Québec, QC, Canada

Similar jobs

Expert Quality Documentation Specialist for Compliance and Accuracy

Institut Rosell-Lallemand Inc.Quebec, Capitale-Nationale, CA
Full-time

Shape quality documentation processes with precision as a Quality Documentation Specialist.Ensure documents meet industry standards, are accessible, and continuously updated, enhancing overall comp...Show more

 • Promoted

QA Specialist III — Elevate Product Quality

Maplesoft Group, an SEB CompanyQuebec, Capitale-Nationale, CA
Full-time

A leading technology consulting firm is looking for a remote Quality Assurance Specialist/Analyst to support their Network Modernization initiatives.Candidates should possess a minimum of 10 years ...Show more

 • Promoted

Implementation Specialist I

AffirmQuebec, Capitale-Nationale, CA
Full-time

Affirm is reinventing credit to make it more honest and friendly, giving consumers the flexibility to buy now and pay later without any hidden fees or compounding interest.As an Implementation Supp...Show more

 • Promoted

Clinical Specialist

ÖssurQuebec, Capitale-Nationale, CA
Full-time

Clinical Specialist page is loaded## Clinical Specialistlocations: Remote Canadatime type: Full timeposted on: Posted Todayjob requisition id: REQ-4726The Canadian Clinical Specialist will be respo...Show more

 • Promoted

Reality Capture Survey & BIM Specialist

Sevan Multi-Site Solutions, Inc.Quebec, Capitale-Nationale, CA
Full-time

Career Opportunities with Sevan Multi-Site Solutions, Inc.Current job opportunities are posted here as they become available.Sevan Multi-Site Solutions is a veteran-owned business that provides con...Show more

 • Promoted

Clinical Integration Specialist - British Columbia

Align Technology, Inc.Quebec, Capitale-Nationale, CA
Full-time

Clinical Integration Specialist - British Columbia.Canada-British Columbia-Field based.IS”) is a practical clinical expert that partners with customers and sales territory managers alike to drive t...Show more

 • Promoted

Remote Media Billing Specialist for Precision in Invoice Management

Syneos HealthQuebec, Capitale-Nationale, CA
Remote
Full-time

Exciting opportunity for a Media Billing Specialist with keen attention to detail in a remote environment.Ensure the seamless execution of billing processes and media activations.This role within t...Show more

 • Promoted

Remote CSV Validation Specialist (Clinical Systems)

TRIO - Translational Research in OncologyQuebec, Capitale-Nationale, CA
Remote
Full-time

A global academic clinical research organization is seeking a Computer Systems Validation Unit Associate I or II for their Quality Assurance team.This remote position involves assisting and leading...Show more

 • Promoted

Configuration Specialist (Ivalua)

CGIQuebec, Capitale-Nationale, CA
Full-time

The Ivalua Configurator is responsible for the configuration, customization, and optimization of the Ivalua platform.This role focuses on translating business requirements into Ivalua configuration...Show more

 • Promoted

QA Specialist

NewformaQuebec, Capitale-Nationale, CA
Full-time

At Newforma, you’ll help shape the future of project information management for architects, engineers, and contractors worldwide.Join a team that’s trusted by over 1,500 firms to simplify how they ...Show more

 • Promoted

Traveling Clinical Applications Specialist with Training Expertise

Siemens Healthineers AGQuebec, Capitale-Nationale, CA
Full-time

Exciting opportunity for a Clinical Applications Specialist in a traveling role.Deliver compelling training to customers and colleagues in English and French while enhancing patient care across the...Show more

 • Promoted

Remote Data Analyst & Validation Specialist

World Web WorksQuebec, Capitale-Nationale, CA
Remote
Full-time

A renowned web services company is seeking a motivated Data Entry Specialist to join their team remotely.This role involves gathering and analyzing data, developing reports, and troubleshooting dat...Show more

 • Promoted

Remote CSV Validation Associate – QA Systems

Translational Research in OncologyQuebec, Capitale-Nationale, CA
Remote
Full-time

A global academic clinical research organization is seeking a Computer Systems Validation Unit Associate I or II to join its Quality Assurance team.This role will involve responsibilities in develo...Show more

 • Promoted

Implementation Specialist

Wicket Inc.Quebec, Capitale-Nationale, CA
Full-time +1

Implementation Specialist – Wicket Web™.Join our team of trailblazers in Association Technology!.Are you ready to make waves in the tech world? At Wicket, we’re at the forefront of technological in...Show more

 • Promoted

Implementation Specialist for AI-Powered Solutions in Accounting

Karbon Inc.Quebec, Capitale-Nationale, CA
Full-time

Lead the implementation process for innovative AI-driven solutions as an Implementation Specialist.Ensure effective onboarding and training for clients, facilitating successful adoption in a remote...Show more

 • Promoted

Expert Billing and Implementation Specialist with Technical Focus

Event TempleQuebec, Capitale-Nationale, CA
Full-time

Transform customer experiences as an Expert Billing and Implementation Specialist.Your expertise will drive seamless billing operations and smooth data migrations, enhancing customer success effect...Show more

 • Promoted

Field Implementation Specialist

Eupry ApSQuebec, Capitale-Nationale, CA
Full-time

At Eupry, we’re on a mission to make compliance effortless across the entire supply chain.From the manufacturer's cleanroom to the global logistics warehouse, we provide wireless monitoring and aut...Show more

 • Promoted

Implementation Specialist

EdealerQuebec, Capitale-Nationale, CA
Full-time

EDealer is a website and software supplier for the Automotive Industry.Our mission is simple: To ensure car dealers build great business and manage inventory.Steadfast in our commitment to create e...Show more