Systems Technology Compliance Senior Specialist

The job involves following departmental Standard Operating Procedures and Work Instructions, completing required training within specified timelines, and auditing System Life Cycle (SLC) activities and documentation. You will be responsible for planning, conducting, and leading global internal facility, system, and process audits, as well as external audits of vendors and suppliers. Additionally, you will participate in client and regulatory visits as a subject matter expert in computerized systems and technology compliance. You will also be involved in authoring and reviewing controlled documents, advising internal business, IT, and QA partners on systems and technology compliance, and leading process and continuous improvement projects. Ensuring Regulatory Compliance and Quality Assurance (RC and QA) responsibilities are followed as per controlled documents is essential. Other duties may be assigned by management. Minimum Qualifications required for this role include a bachelor's degree in Life Sciences or equivalent experience in Life Sciences. Relevant and equivalent experience may be considered in lieu of educational requirements. Experience of at least 4 years in a regulatory environment with system compliance experience is necessary. A sound understanding of standard computer system development life cycles is required to provide guidance to both information technology and operational personnel. Thorough knowledge and understanding of GxP and computerized systems regulations and regulatory guidelines is essential. Experience in applying regulations in at least one GxP discipline and computerized systems standards to drug development is preferred. Strong analytical, organizational, and interpersonal skills are required along with the ability to confidently interact with clients and regulatory personnel, conduct effective training, and negotiate ideas and suggestions effectively. Preferred Qualifications include a bachelor's degree in Life Sciences or equivalent experience in Life Sciences. The job entails working in 2nd shift hours from 2 PM to 11 PM IST. Tasks involve sitting in front of a terminal for extended periods during the working day. Some overtime and weekend work may be required, and regional travel of up to 5% of the time may be necessary. For further details about Equal Employment Opportunity (EEO) and Accommodations requests, please refer to our website.,