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Junior Officer FDA

Home Career Junior Officer FDA

Expression of Interest

Location: Remote
Designation: Junior Officer
Department: USFDA
Purpose of the Document: The document below assists candidates in understanding the working pattern and job criteria for home-based US FDA regulatory consulting services, as well as employers in understanding the employee’s desire and commitment.

1 I hereby submit the necessary information to the employer in order for them to examine my technical abilities, professional competence, and background check.
2 As a responsible professional, if I am selected, I pledge to respect the confidentiality of all customer-supplied information and technical specifications with the utmost care.
3.1 Professional fee during 4 months of adaptation period: 18000 INR per month
3.2 Professional fee after adaptation period: 20000 INR per month
3.2.1 Professional fee increases based on technical capability, problem solving, man-day utilization, handling of customer queries and overall profit generation from the allocated projects.
3.2.2 TDS will be deducted as per India Govt Rules.
3.2.3 Absences of four days or more in a row, including Saturday and Sunday, will be considered leave, and professional fee will be deducted for the entire period.
3.2.4 Timings for login and logoff shall be entered in the web portal. The professional fee will be calculated based on attendance.
4 Working days are from Monday to Friday. Weekly off on Saturday and Sunday.
4.1 Work Timing is from 0900 - 1800. 8 Hours per day. 40 Hours per Week
4.2 Work Time will be monitored via installed software's
4.2.1 Work computer will be monitored from 8 am to 7 pm on all working days including Saturdays.
4.2.2 With the approval of the team manager, candidates can make up lost work days in any on Saturdays.
5 During working hours employees must be accessible at any point of time on Skype, Mobile, WhatsApp & Email (Outlook).
5.1 All incoming calls from clients and team members must be answered on all working days days including Saturdays.
5.2 Candidates are required to maintain the same contact number throughout the tenure.
6 Candidates will be provided domain linked Email ID for communication and the same must be used for Skype and Dropbox and all other related applications. The password should be protected.
6.1 All critical technical matters should be communicated through emails only. Avoid verbal communication.
6.2 All internal communication via Skype and WhatsApp and Outlook application.
7 Job Responsibilities.
7.1 Label compliance according to USFDA regulations, 510k submissions, Drug registrations etc.
7.2 Coordinate and communicate with domestic and International customers
7.3 Communicate in a pleasant and courteous manner with our colleagues, corporate associates, and customers. During Skype or Zoom meetings, you must be properly attired and ensure that there is no noise in the room.
7.4 All documents approved by customers are customer property and all documents prepared by the team members are the property of I3CGlobal. No copying or transfer allowed.
7.5 Complete projects on timely manner as per instruction. Report to team lead and Principle Consultant.
8 Job Requirements.
8.1 Minimum computer specification: i5 processor, 8 GB RAM, SSD hard disk, Windows 10, Office 2016, with clear voice and video
8.2 Candidates work place should have access to minimum 4 Mbps Data UPLOAD speed.
8.3 All documents must be developed in the cloud. Weekly scanning for antivirus.
8.4 Any unwanted programs which disturb the performance of the computer should be avoided.
8.5 When called to the Bangalore office 1-2 times a year, candidates must be able to engage in team functions and training.
8.6 Candidates must be willing to attend zoom meetings of overseas customers during late hours if required.
9 Management Requirements.
9.1 Candidates must inform about proposed leaves in advance for the smooth planning and scheduling the internal activities.
9.2 Candidates must intimate at least 45 days prior intimation about career change / Resignation.
9.3 Candidates must voluntarily withdraw from the role if they are unable to (a) login and logoff on time, or (b) have a disruption at home that interferes with the quality of their work and team meetings. Such applicants must resign within two weeks of being hired.
9.4 Management has the right to terminate (a) if the candidate does not recognize the job duties during the adaptation process (b) if the candidate is often absent (c) if the candidate's work is of low quality (d) if the candidate's time management is poor.
10 Applicant Declaration.
10.1 Myself willing to work in the organization and would like to be a part of I3CGLOBAL regulatory team for a minimum period of 1 year from the date of joining at my present capacity and family circumstances.