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Executive / Senior Executive- IT (CSV)
Enzene Biosciences LtdDelhi, India6 days ago
Job descriptionPerform validation of computer systems in compliance with industry standards. Develop and execute validation strategies, including risk assessments and validation protocols. Collaborate with cross-functional teams to ensure seamless integration and operation of validated systems. Develop and implement validation strategies for computer systems and applications. Ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP). Coordinate and execute validation testing, including IQ, OQ, and PQ. Provide training and support to IT and business teams on validation processes and requirements. Participate in internal and external audits, providing necessary documentation and support. Continuously improve validation processes and procedures to enhance efficiency and compliance. Prepare and present validation reports and findings to stakeholders and management. Troubleshoot and resolve validation-related issues as they arise. Skills in executing User Acceptance Testing (UAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Knowledge of system lifecycle management and change management processes. Strong knowledge of regulatory requirements and industry standards related to computer system validation. Experience with validation of various types of systems, including ERP, LIMS, and MES. Proficiency in enterprise systems, quality control (QC) systems, and manufacturing equipment validation. Strong analytical skills for identifying and resolving validation-related issues. Ability to conduct root cause analysis and implement corrective actions. Experience with project management methodologies (e.g., Agile, Waterfall).
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Executive It • Delhi, India
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