SME For Computer System Validation Syngene International Limited

8.0 - 15.0 years

0 Lacs

karnataka

On-site

The role of SME - Computer System Validation at Syngene in Bangalore involves ensuring compliance with regulatory requirements such as 21 CFR Part 11 and EU Annex 11. Your responsibilities include validating computerized systems used in manufacturing and quality control processes, as well as supporting the implementation of new regulations and technologies in life sciences. You will coach the IT team on regulatory requirements for CSV/CSA and Data Integrity, contributing to maintaining regulatory compliance and promoting a culture of compliance within the team. As the SME - Computer System Validation, you will be accountable for ensuring the accuracy, completeness, and compliance of validation deliverables, coaching the IT team and users, aligning computerized system validation procedures with regulatory expectations, providing guidance on infrastructure qualification, recommending corrective and preventive actions, maintaining the validated state of application systems and IT infrastructure, conducting periodic reviews, and managing audits effectively. To excel in this role, you should have 8 to 15 years of experience in the pharmaceutical and IT service industry, with expertise in areas such as Computer System Validation, Computer System Assurance, Data Integrity, ERES Implementation, IT Application Lifecycle, Quality Management System, and Audit management. Your skills should include proficiency in Computerized System Validation, enterprise and site-specific rollout of IT applications, validation of COTS and infrastructure products, ERES implementation and GAP assessment, test script writing and execution, software development models, IT quality management, IT security, data lifecycle management, and project management. The ideal candidate will possess a post-graduate Master's Degree/Diploma in Computer Science and Application or equivalent, along with certifications in ITIL and Agile methodologies. By demonstrating alignment with Syngene's core values of Excellence, Integrity, and Professionalism, you can contribute effectively to maintaining compliance with regulatory requirements, ensuring the accuracy of validation deliverables, supporting the professional development of the IT team, and managing audits efficiently. Syngene is an Equal Opportunity Employer committed to fostering a diverse and inclusive workplace where all employees are valued and respected.,

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