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Job Location drjobs

Kolkata - India

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Lab Tester (Experience 3 to 8 years).

  • Experience/ exposure to US FDA 21 CFR Part 11 EU Annex 11 and GAMP 5.
  • Experience in testing and knowledge in any one of the Lab systems (LIMS CDS SDMS etc) is must.
  • Should worked in pharmaceutical domain and its related knowledge is must
  • Good communication and technical writing skills are a must
  • Developing validation documentation for pharmaceutical equipment facilities and computerized systems used in GLP GMP and GCP environments.
  • Project Deliverables will encompass specifications test protocols and standard operation procedures and systems may include Process Automation Laboratory Automation Enterprise IT Applications and Network Infrastructure.
  • Prepare and execute TP IQ OQ PQ TSR Traceability Matrix FRA
  • Exposure to Regulatory Audits
  • Using previous use cases and best practice counsel on highly regulated environments
  • Knowledge on working in Jira HP ALM or any automation testing tools

Employment Type

Full Time

Company Industry

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