Quality Control Technician III

Teva Global Business Services

Goa

On-site

INR 700,000 - 1,100,000

Full time

13 days ago
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Job summary

Teva Global Business Services in Goa, India, is seeking a qualified analytical chemist to develop and validate nitrosamines methods using LCMS, GCMS, and IC under guidance from senior team members, with responsibility for efficient sample handling across sites.

You will conduct routine instrument operation, calibration, and maintenance, maintain documentation, contribute to internal audits, and help readiness for external inspections while adhering to EHS guidelines.

Qualifications

  • M.Sc. in Chemistry or M.Pharm required.
  • 3–5 years hands-on experience in analytical method development and validation.
  • Strong knowledge of nitrosamines impurities analysis in drug substances/products.
  • Familiarity with TrackWise and Veeva Vault.
  • Experience in cGMP/GLP environments and regulatory documentation.

Responsibilities

  • Develop and validate analytical methods for nitrosamines using LCMS, GCMS, IC.
  • Manage samples from different sites for Nitrosamine project.
  • Test samples for nitrosamines-related activities.
  • Troubleshoot analytical instruments and day-to-day operations.
  • Maintain prerequisites such as columns, standards, chemicals, and consumables.
  • Prepare analytical protocols, reports, and regulatory-compliant documentation.
  • Perform routine instrument operation, calibration, and maintenance; escalate issues.
  • Document instrument usage and calibration records.
  • Adhere to EHS guidelines and safe lab practices.
  • Support internal audits and readiness for external inspections.

Skills

Analytical method development
Analytical method validation
cGMP/GLP
Regulatory documentation
Team collaboration

Education

M.Sc. in Chemistry
M.Pharm

Tools

TrackWise
Veeva Vault

Job description

Role & responsibilities :

Develop / Validate analytical methods for nitrosamines related activities using LCMS, GCMS, IC under guidance from senior team members.
Management of samples received from different sites for Nitrosamine project.
Testing of samples for nitrosamines related activities .
Trouble shooting of analytical instruments for difficulties faced during day-to-day operations.
Contribute in maintaining the prerequisites for Laboratory such as Column, Standards, Chemicals, Spares and Consumables etc.
Preparation of analytical protocols, reports, and technical documentation in compliance with regulatory standards.
Conduct routine instrument operation, calibration, and maintenance activities; escalation issues for troubleshooting.
Ensure accurate documentation of instrument usage, calibration records, and compliance.
Adhere to EHS guidelines and maintain safe laboratory practices.
Laboratory compliance and data integrity during day-to-day operations.
Participate in internal audits and contribute to readiness for external inspections.

Qualification:

M.Sc. In Chemistry or M.Pharm
Experience: 3-5 years of hands on experience in analytical method development and validation.
Good Knowledge of Analytical Chemistry especially in Analytical method Development & Validation for Nitrosamine Impurities in Drug Substance and Drug Product and logical approach.
Literature Search for development of analytical methods.
Familiarity with computerized systems such as TrackWise, Veeva Vault
Experience in cGMP/GLP environments and regulatory-compliant documentation.
Strong attention to detail and ability to work effectively in a team setting.
Good communication skills (oral and written).
Sound knowledge of pharmaceutical Quality System, ICH guidelines etc.

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