Engineer

Tech Qualitas

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.E, B.Sc

• 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