Executive/Senior Executive- IT

As a Computer Systems Validation Specialist, your role involves performing validation of computer systems in compliance with industry standards. You will develop and execute validation strategies, including risk assessments and validation protocols. Collaborating with cross-functional teams is crucial to ensure seamless integration and operation of validated systems. Your responsibilities will also include developing and implementing validation strategies for computer systems and applications. Key Responsibilities: - Coordinate and execute validation testing, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (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. - Execute User Acceptance Testing (UAT) and ensure compliance with regulatory requirements (e.g., FDA, EMA) and industry standards (e.g., GAMP). Qualifications Required: - 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). This role requires a detail-oriented individual with a strong understanding of computer system validation processes and industry standards. Your expertise will contribute to ensuring the efficient and compliant operation of validated systems within the organization.,