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Salaryurgent hiring for Desktop support engineers for pharmaceuticals for Dewas locations.
Job Responsibilities-
Ensure GxP compliance in all IT-related activities.
Perform backup and restoration for site-specific applications in QC, manufacturing, and engineering.
Prepare or revise site-specific IT SOPs to ensure compliance
Support CSV activities related to IT at site
Represent site IT during all external audits
Co-ordinate with external IT vendors to ensure uptime
Coordinate with the IT team for all enterprise application support.
Understanding of the process in a pharmaceutical R&D and manufacturing environment
Involvement in CSV (Computer System Validation) requirements of IT
Desktop support engineer with knowledge of resolving IT tickets and collaboration with users for day-to-day IT-related inquiries.
IT Asset Handling
Record keeping and handling
Hands-on experience in backup schedule management and performing daily backup activities.
Hand on experience in Scheduled Archival and restoration testing as per procedure.
OEM support for Internal IT requirements.
Having knowledge on implementing Group policy on GxP systems. Should have experience in preparing backup logs.
Knowledge on patch fixing and Rebooting PC systems.
Sound knowledge on user creation and user administration related requirements
IT QMS handling experience, With Knowledge on CAPA deviation and change Control management Handle administration of site-specific applications in QC, Manufacturing and Engineering.
Define and Translate the Validation Strategy to Validation plan for the Highly Regulated Environments to achieve high standards of GLP/GCP/GMP.
Should have good knowledge of regulations 21 CFR, GAMP5, Annex 11, GxP etc.
Knowledge of GxP Analysis and Gap Assessment and it's mitigation actions.
Good Communication, Interpersonal and Customer Interfacing skills the ability to articulate and explain information to customers and senior managers
Author key validation deliverables like Validation Plan, Test Plans, Summary reports, etc.
Understand and adhere to the Quality manual, SOP on Project Management, Change Management, Document Management, and Quality Management;
Execution of Validation activities, experience in writing, reviewing, and executing computer validation deliverables (Validation Plan, IQ, OQ, PQ, RTM, Impact assessment, UAT, SOP's, Summary report) for both on-premise and Software as a Service (Cloud hosted) applications used in Pharma/Life Sciences industries.
Good Knowledge of Data Integrity, ALCOA principles, etc.
Interested candidate please share your resume at ankur.tiwari@ics-india.co.in
Call us;- 9109188512
