Job Description :

We are seeking an experienced Validation Testing / IT QMS Specialist with 49 years of experience in Quality Management Systems (QMS), IT compliance, validation, and regulated environments.

The ideal candidate will be responsible for supporting and maintaining IT Quality Management System processes, ensuring compliance with regulatory standards, managing controlled documentation, and supporting validation, audit, and training activities. The role requires close collaboration with IT, Quality, and business stakeholders to ensure systems and processes meet organizational and regulatory requirements.

Requirements :

- 4 - 9 years of experience in IT Quality Management Systems, Validation, Compliance, or Quality Assurance roles.

- Strong understanding of Quality Management Systems (QMS) and regulated environments.

- Experience with regulatory frameworks and standards such as FDA, GxP, ISO 13485, ISO 27001, and related compliance requirements.

- Hands-on experience with electronic Quality Management Systems (eQMS).

- Knowledge of Computer System Validation (CSV), system qualification, and validation lifecycle methodologies.

- Experience supporting audits, inspections, compliance reviews, and corrective action programs.

- Understanding of CAPA, deviation management, change control, and risk management processes.

- Experience managing controlled documents, SOPs, policies, work instructions, and quality records.

- Strong documentation, analytical, and problem-solving skills.

- Excellent communication and stakeholder management capabilities.

- Experience working with cross-functional teams in IT, Quality, Compliance, and Business functions.

Responsibilities :

- Support the development, implementation, and maintenance of IT Quality Management System (QMS) processes, procedures, and documentation.

- Ensure IT policies, SOPs, templates, and work instructions comply with applicable regulatory and organizational requirements.

- Manage document lifecycle activities within the electronic Quality Management System (eQMS), including authoring, review, approval, revision, and retirement.

- Support validation and qualification activities to ensure compliance with QMS and regulatory standards.

- Collaborate with IT and Quality teams to ensure validation deliverables meet quality and compliance requirements.

- Coordinate and support IT audits, regulatory inspections, and quality assessments.

- Prepare audit documentation, respond to auditor requests, and track audit findings through closure.

- Manage and monitor CAPAs, deviations, non-conformances, and change management activities related to IT systems and processes.

- Support training programs and ensure personnel compliance with required quality and regulatory training.

- Assist in risk assessments, process improvements, and continuous quality initiatives.

- Maintain accurate records and documentation to support compliance and audit readiness.

- Monitor quality metrics and contribute to ongoing improvements in IT quality and compliance processes.