Kushal Shethwala Email & Phone Number

Ahmedabad, Gujarat, India

1. Work with concerned user departments to understand their requirements/issues to provide support by implementing systems, procedures, and policies to comply with regulatory expectations with IT and Business compliance.2. Communication with Software development team for the applications testing, debugging, coding, creation, and design.3. Documentation and record maintenance for relevant/applicable IT business and compliance processes.4. Initiates, maintains, and revises applicable IT procedures, software operations, software validations activities and validation documentation to mitigate IT risks against data integrity requirements.5. Develops initiates, maintains, and revise IT policy and procedures to mitigate IT risk against data integrity requirements.6. Identify and leverage opportunities to continually improve the quality of IT systems and processes to meet the current industry standards that result in achieving data accuracy and compliance for proper data integrity.7. Assist IT Compliance /Infra/Core IT and Software development team in routing activities with sharing the knowledge, experience, ideas and information.8. Supervising overall functioning of business i.e IT of company to ensure efficient and effective management of process at all the locations of the company.9. Reporting to Head-IT and VP-IT for IT and business application related activities and provides reports on a regular basis for requirement and progress of project status.10. Maintain awareness of recent trends and advance technology for application and IT process.

Vadodara Area, India

1. Initiates, maintains, and revises applicable IT procedures, software operations, software validations and documentation to mitigate IT risks against data integrity requirements. 2. Develops/implements corrective action plans for resolution of problematic IT compliance issues to meet with the user IT requirements. 3. Handling and management of routine electronic data backup, electronic data archiving and electronic data including backend database, instrumental data and other file formats. 4. Conduct IT specific audits for various activities like vendor qualifications, departmental process/systems, documentation etc. 5. Work with concerned user departments to understand their requirements/issues to provide support by implementing systems, procedures, and policies to comply with regulatory expectations with IT compliance. 6. Documentation and record maintenance for relevant/applicable IT compliance processes. 7. Prepare reports for head/management and external regulatory bodies as and when required. 8. Reporting to Head of Compliance IT for IT compliance related activities and provides reports on a regular basis for requirement and progress of compliance efforts. 9. Conforms to training schedule for own position and maintains awareness of SOP content, according to company requirements. 10. Maintain awareness of recent trends and advances for IT processes.

Ahmedabad Area, India

Current Job Responsibilities:1. To perform and document all activities related to CSV.2. To maintain documentation status related to CSV.3. To face regulatory audits (USFDA, MHRA, WHO)/ sponsor audits and answer queries related to CSV and software.4. To act as an administrator for applicable software.5. To prepare and review IT SOPs.6. Maintain inventory and other documents related to IT department.7. To create users and provide access rights.8. To manage and monitor data backup.9. To install and maintain all computer software drivers (shared Printer/Copier).10. To solve computer hardware related problem. (Printer, scanner, fingerprint scanner, web cam, laptop etc.)11. To maintain data security.12. Monitor temperature and humidity in server room.13. Authority to Sign: Standard Operating Procedures and Related documents, Perform all IT related activities in the absence of Administration head and sign relevant documents.

Ahmedabad Area, India

Handled different projects at different locations of India and outside of India.Projects Executed in India:  GVK Biosciences Private Limited, Hyderabad : Lab Validation Biological E. Limited, Hyderabad : Lab Validation Aurobindo Pharma Limited, Hyderabad : Oracle Application Implementation (ERP) Claris Life Sciences Ltd. (CL-5), Ahmedabad : Lab Validation Amneal Life sciences Private Limited, Ahmedabad : Lab Validation Amneal Pharmaceuticals Private (I) Limited, Ahmedabad : Lab Validation Accutest Research Lab (I) Pvt. Ltd., Mumbai : Lab Validation Medley Pharmaceuticals Limited, Daman : Lab Validation Wallace Pharmaceuticals Pvt. Ltd., Goa : Progen ERP Validation, Lab ValidationProjects Executed outside India: Square Pharmaceuticals, Bangladesh : Lab Validation, PLC Validation

B.E, Electronics & Communication Engineering

12Th, Science Stream

10Th