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IT Operation and Complaince

3.00 to 4.00 Years   Delhi   05 May, 2023
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    • Overall adherence to safe practices and procedures of oneself and the teams aligned
    • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company s integrity & quality standards
    • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
    • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
    • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
    • Compliance to Syngene s quality standards at all times
    Core Purpose of the Role :
    • Support to IT Compliance Activities in Discovery and Development Services.
    • Support to IT Operational Activities in Discovery and Development Services.
    • Support to IT User Management Activities in Discovery and Development Services.
    Role Accountabilities
    • Act as administrators in Operating Systems (OS) and Instrument/ Equipment connected application software Discovery & Development Labs areas for Systems Administration, Troubleshooting, and Data Backup/Restore Management.
    • Responsible for identifying the data from instrument/equipment connected application software in Discovery & Development Labs areas schedule their backups in backup solution software (i.e., Commvault) and maintain the list as per SOP requirements.
    • Responsible for Performing/Monitoring the data backup as per schedule or manually and maintain the backup media and activities logs as per SOP requirements.
    • Responsible for Performing the data restore on user s requests/ periodically, verify it along with users and maintain their activities logs in line to SOP requirements.
    • Responsible for performing and maintaining the activities logs logging the applications administration activities such as System Configuration & Security Policies Implementation, Privileges & Roles Management, User Management - User Creation, Modification, Enable/Disable, Lock/Unlock etc.) as per SOP for the Discovery& Development Labs systems.
    Syngene Values All employees will consistently demonstrate alignment with our core values
    • Excellence
    • Integrity
    • Professionalism
    Specific requirements for this role
    1. Experience
    Minimum 3-4 years of working experience with Pharmaceutical / Life Science / Health Care Industry
    1. Demonstrated Capability
    2. Education
    B.E. / B. Tech / MCA / BCA / MSc IT / BSc IT /Etc. Skills and Capabilities
    • Hands on experience on QC / R&D and Pharma instruments application like KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR, FT-IR, Ph-Meter etc.
    • Hands on experience on User Management Activities (User Creation / Modification / Deactivation / Password Reset) and Support in Audit Trail Review.
    • Hands on experience on Data Management Activities (Backup, Restoration and Archival) of Instrument connected application.
    • Hands on experience on Compliance Activities (Change Control, Deviation and CAPA etc.)
    • Hands on experience on Informatics Application and Lab Computing support, troubleshooting and vendor coordination.
    • Candidate should be well versed with Standard Operating Procedure keeping regulatory compliance audits.
    • Should have strong understanding for 21CFR part 11 specially data integrity and compliance.
    Other Skills
    • Ability to work within an interdisciplinary research team.
    • Good written and communication skills.
    ,

Keyskills :
it compliancedata integritydata management

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