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.
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.
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.
Generate validation documents for clients based on the functional and design specifications of the projects.
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. Partner with various internal departments to deliver validation documentation at specific stages of project development.
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. ~ 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.
Strong curiosity and a willingness to learn and adopt new technologies, especially artificial intelligence. Adaptable working hours Employee Assistance Program (EAP) We believe that diversity is essential to fostering innovation and creativity. At OPTEL, each employee’s unique perspective contributes to our collective success, and we celebrate the richness that diversity brings to our tea