Desktop Support Engineer(Pharma)

0-2 years
a month ago 5 Applied
Job Description

urgent hiring for Desktop support engineers for pharmaceuticals for Halol (Gujarat) 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 [Confidential Information]

Call us;- 9109188512

JOB TYPE

Industry

Other

Function

Skills

Uat
Rtm
Csv
IT QMS
PQ
enterprise application support
Scheduled Archival
CAPA deviation
Gap Assessment
Summary report
computer validation deliverables
backup schedule management
Annex 11
GxP Analysis
GAMP5
OQ
ALCOA principles
IQ
Validation Plan
OEM support
SOP"s
IT SOPs
change Control management
IT vendors
21 CFR

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