Executive/Senior Executive- IT

4 weeks ago

Chakan Maharashtra India, IN Enzene Biosciences Ltd Full time
  • Perform 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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