Requirements :-
Bachelor’s degree preferably in Computer Science, Data Science, or a related field is an advantage.
3-5 years of experience in Software Validation, IT, Testing, Medical or Pharma industry.
Experience with external audits and /or conducting internal audits.
Working knowledge of ISO 13485, ISO 27001, and ISO 14971 is an advantage.
Fluent in English.
Job Responsibility :-
Ensure company-wide alignment to the Knowledge Management Software Validation Process and initiatives, and work closely with key business users and stakeholders.
Support cross-functional initiatives to validate various in-house and enterprise software such as, but not limited to, our Learning Management System (LMS), Quality Management System (QMS), Digital Asset Management System (DAM), and various software used during product design & development.
Create and Maintain a company-wide software catalog with key business stakeholders and communicate regularly to ensure the right information is captured and maintained.
Coordinate and lead regular awareness campaigns and workshops with businesses on Validation Process, System Validation, QARA Regulations, and Standards applied.
Create and maintain Knowledge Management quality documents like SOPs, Forms, Templates, and Work Instructions.
Perform routine data backups, inspections, and quality tests.
Support stakeholders from all departments in software periodic reviews, follow-up, and creating strategies and policies to ensure all systems are maintained in their validated state.
Proven experience with IQ / OQ / PQ, specification, and execution of verification and validation protocols.
Analysis and documentation of test scenarios and test cases.
Automation testing platforms (e.g., Bamboo, IBM Rational Test, HP ALM, etc.).
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