Sathram Corporation / Employee Referral Program
It's our way of thinking about helping our family of team members grow.
Sathram Corporation appreciates your referrals-and the Team Member Referral Program is our way of showing it! We're always excited to recruit candidates among the likes of our talented and most valued team members. You know best who you would like to work alongside-- those team members who are as committed to quality and to our seniors as you are. We are honored that you recommend Sathram Corporation as an employer of choice for your friends and family, and thank you for the time and effort you put into making referrals.
The following job posting will be listed on our site as well as will be posted in the Star Ledger NewsPaper, etc. However, if anyone knows someone that meets the requirements and is looking for a job, please forward me their resumes for consideration. There is a monetary incentive of $ 500 for anyone referring a candidate within 30 days of the referral's hire.
Sathram Corporation has openings for the positions:
Regulatory Affairs Specialist
Regulatory Affairs Specialist with Master’s degree in Technology, Proj Mgmt, Any Analytical Science or related to perform acceptance review and comprehensive substantive review of the 510(k) submissions to ensure it is administratively complete and scientifically complies with the FDA regulations and guidelines. Submit notifications to J&J Regulatory Affiliates pertaining to changes to Product, Manufacturing, Quality, Packaging and Labeling. Provide solutions to a variety of problems of moderate scope of complexity.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Validation Specialist
Validation Specialist with Master’s degree in Computer Science, Engineering any, Technology, Any Analytical Science, Health Informatics or related to work on developing process flow diagrams and execution of process and product FMEA risk analysis. Authoring qualification related documents for pharmaceutical and laboratory equipment such as IQ, OQ and PQ. Creation of validation package and coordinate with QA for document archival and audit preparation. Execute validation plans, requirement specifications and validation protocols including installation, operation and performance qualification.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA based on client assignments. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Clinical Trial Manager
Sathram Corporation has openings for the position Clinical Trial Manager with Master’s degree in Public Health or related and 1 yr of exp to work on development of study synopsis, protocols, and protocol amendments, IB, CSR. Responsible for managing and creating trial related plans such as communication plan, project oversight plan, monitoring plan,TMF Plan, Data Management Plan, SOP’s. Involve in reviewing essential documentation related to clinical studies ensuring. Involve in the creation of study preparation materials for investigator meetings, site training, meetings. Manage all clinical aspects of study, including: managing study timelines and metrics; participates in selection and management/oversight of external vendors; reviews vendor reports, budgets, and metrics.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Validation Engineer
Validation Engineer with Master's degree in Computer Science, Engineering any, Technology or related and 1 yr of exp to analyze validation data, prepare reports including preparation of standard operating procedures by adhering to FDA, cGMP standards. Develop and execute of Validation plans (VP), Validation Protocols (IQ, OQ and PQ),GxP assessment, Requirement Traceability Matrix (RTM) and Summary Reports (Validation summary reports VSR) and develop Standard Operating Procedures (SOPs).Perform GAP Analysis, Remediation Plan and maintenance of hybrid systems, close and open record systems in cleaning validation.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Regulatory Affairs
Regulatory Affairs with Master's degree in Regulatory Affairs or related to work on establishing Dossier Plans for the assigned submission types / projects considering inputs from functional area representatives and key stakeholders. Maintaining effective interactions with relevant stakeholders and other RSMO colleagues as appropriate to ensure priority conflicts, resource issues and deviations from the plans are identified and resolved. Ensuring relevant submission process(es) are applied to all assigned submissions, including coordinating the electronic component and dossier level publishing and production of regulatory submissions that conform to regional and country specific regulatory requirements as appropriate. Monitoring the effectiveness of appropriate submission processes with responsibility for initiating changes within the scope of decision-making authority to minimize inefficiencies and ensure quality. Meeting regularly with submission stakeholders to identify and resolve issues and to assess quality and delivery of Dossier Plans, quality of deliverables and timelines against established KPIs. Interfacing with cross-functional representatives as appropriate to manage the dossier preparation process and ensure all aspects of the plan are coordinated and executed efficiently. Ensuring dispatch/distribution in compliance with due dates to Health Authorities and/or Local Operating Companies, as applicable. Tracking submission events/activities in appropriate systems/tools.
Work location is Plainsboro, NJ with required travel to client locations throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail : hari@sathramcorp.com
Software Validation Engineer
Software Validation Engineer with Master's degree in Computer Science, Engineering, Technology, or related and 6 months of exp to meet health authorities' regulations and requirements. Develop Requirements Specification, IT System builds specifications, Software Design Specifications, System Architecture, and Configuration Specifications for Enterprise IT systems and cloud-based computerized systems and applications. Validate Infrastructure including Infrastructure as a Service (IaaS), Platform as a Service (PaaS), and Software as a Service (SaaS). Develop a Test Strategy and plan to execute testing for configuration and customization done to the system to meet user requirements. Develop SQL Scripts to validate the source data with respect to the application data. Perform GAP Analysis, Remediation Plan, and maintenance of hybrid systems, close and open record systems in cleaning validation. Monitoring and Testing Equipment like managing, Inspects, and Calibrates the instrumentation, Execution of Commissioning and Qualification also Analyzing and documenting test results Provide a Process description that is about the Mechanical and automated functions of the system, Responsible for Walking down P&ID’s, Documenting and recording the test results.
The work location is Plainsboro, NJ with required travel to client locations throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail: hari@sathramcorp.com
Validation Specialist
Validation Specialist with a master's degree in computer science, Engineering, Technology, Any Analytical Science, Health Informatics, or related in developing process flow diagrams and execution of process and product FMEA risk analysis. Authoring qualification-related documents for pharmaceutical and laboratory equipment such as IQ, OQ, and PQ. Creation of validation package and coordination with QA for document archival and audit preparation. Execute validation plans, requirement specifications, and validation protocols including installation, operation, and performance qualification.
The work location is Plainsboro, NJ with required travel to client locations throughout the USA. Please mail resumes to 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 (or) e-mail: hari@sathramcorp.com
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Sathram Corp 666 Plainsboro Road, Suite 1236, Plainsboro, NJ 08536 - Email:
hr@sathramcorp.com - Phone:
732-380-5181 - Office Hours:
Monday - Friday : 9.00AM - 5.00PM