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.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