03 Oct
|
Molex
|
Bengaluru
Your Job
As a Technology Compliance Specialist, you will play a critical role in ensuring that GxP computerized systems remain compliant, validated, and inspection-ready throughout their lifecycle. You will partner with Quality, Business, Digital, and technical stakeholders to apply risk-based validation practices that protect product quality, patient safety, and data integrity while supporting business objectives in a global setting.
Our Team
The Technology Compliance Specialist will join the Molex Cybersecurity team, supporting the validation and compliance of global GxP computerized systems. The team works closely with Business Process Owners, Quality Assurance, Digital Teams, System Owners, and suppliers to maintain compliant, secure, and reliable systems that meet regulatory expectations and support operational excellence.
What You Will Do
• Partner with business, quality, and technical stakeholders to define intended system use and establish risk-based validation strategies for GxP computerized systems.
• Lead and facilitate risk assessments,
including FMEA and data integrity evaluations, to identify compliance risks and ensure appropriate validation controls.
• Develop and maintain validation lifecycle documentation, ensuring traceability, technical accuracy, regulatory compliance, and audit readiness.
• Design and execute risk-based validation testing, assess defects and deviations, and drive resolution activities to maintain validated system status.
• Support Quality Management System (QMS) processes including Change Control, CAPA, Deviations, and Document Management while ensuring appropriate CSV oversight.
• Evaluate cloud-based solutions, supplier validation evidence, and software releases to determine compliance impact and validation requirements.
• Collaborate across global functions to maintain inspection-ready systems, support audits, and continuously improve validation effectiveness and compliance processes.
Who You Are (Basic Qualificatio
📌 Technology Compliance Specialist (Bengaluru)
🏢 Molex
📍 Bengaluru