Job Information
Cognizant Analyst in KOLKATA, India
Job Summary
We are seeking a skilled Analyst with 3 to 8 years of experience in Validation and Testing in Labware LIMS Labvantage LIMS GLIMS CDS and any Lab Systems.
Responsibilities
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
Certifications Required
Certified LIMS Administrator Labware LIMS Certification Labvantage LIMS Certification
Cognizant is an equal opportunity employer that embraces diversity, champions equity and values inclusion. We are dedicated to nurturing a community where everyone feels heard, accepted and welcome. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other protected characteristic as outlined by federal, state or local laws.