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
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