Engineer

  • icon job experience 2 - 7 Years
  • icon job opening 5 Openings
  • icon salary Not Disclosed
  • icon job location Mysore
  • Face-to-Face interview Face-to-Face interview
Key Skills

Lead Engineer GxP System

Job Description

About Tech Qualitas

Tech Qualitas is a quality-driven service provider focused on serving the pharmaceutical, biotech, medical device, and CRO companies in following areas/domains:

Computer System Validation

IT/QA Services

GDPR, HIPAA Compliance

Spreadsheet Validation

Auditing Services (Third Party GMP Audits, Internal Audit Management Program, Vendor and Supplier Management Program, Response to Audit Observations)

Compliant & Secure Software Development Life Cycle

Sterilization Process Validation (Gamma Sterilization as per ISO , EO Sterilization as per ISO , Steam Sterilization as per ISO /WHO PDA Technical Report Series etc.)

Consultancy for Pharmaceutical Microbiology and Contamination Control (Facility Walkthrough and Assessment, Utilities Assessment, Clean Rooms/HVAC Validation and routine controls, Cleaning Validation, Sterility, Bioburden, Endotoxin, Disinfectant Validation, Media Fill Validations, Water Analysis as per USP chapters)

Job Title

Engineer/Lead Engineer GxP Systems at GMP Sites

Your Job Responsibilities

As an Engineering Lead, you will be responsible for overall IT Administration of GxP Systems including

User Account Management on daily basis Creation, Removal, Periodic Review

Daily/Monthly/Yearly Backup, Restoration and Archival of all GxP Systems (Instruments, IPCs, HMIs, Servers and Application)

Installation of application on clients

Provide support as an Administrator to Application/System Vendors

During Qualification of new Application/Instruments, provide support as an Executor to Service Engineer & QC team

Applying Security group on Local Drive of Computer system for restricting access & deletion of data

Documentation Maintenance such as Active Users List, Backup Logs, Labelling of backup tape media and maintaining the log of media with retention data etc.

Prepare Monthly/Annual Preventive Maintenance Planner for Computers, Servers, UPS, etc.

Administration of QC and Production Domain
  • Experience

    2 - 7 Years

  • No. of Openings

    5

  • Education

    B.C.A, B.Sc, B.E

  • Role

    Lead Engineer

  • Industry Type

    IT-Hardware & Networking / IT-Software / Software Services

  • Gender

    [ Male / Female ]

  • Job Country

    India

  • Type of Job

    Full Time

  • Work Location Type

    Work from Office

About Tech Qualitas

Tech Qualitas is a quality-driven service partner focused on risk minimization. Our team have more than 40 years of experience handling complex projects in different scales. We are serving the pharmaceutical, biotech, medical device, and CRO companies by providing compliant outsourced services, validation technology solutions support, SaaS product validation and development that improve performance, data integrity, privacy controls, and compliance.
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