Team Lead-QA CSV

Found in: Talent IN C2 - 2 weeks ago


Noida, India YO HR CONSULTANCY Full time
TeamLeadCSVLocation:NoidaExperience:1012Years
MustHave:Experiencein CSV (Computer SystemValidation)Understanding of the regulatoryguidelines for IT systems primarily FDA EMA MHRA andPMDA
JD:1.Exposure to pharmacovigilance domain and drug safety applicationsArgus or ArisG/J strongpreference2. Overall 10 Years ofexperience3. Experience with electronicQMS/DMS is a plus.4. Experience in Manualexecution and ALM Tool based executions5.Experience with training coordination andmanagement6. Worked in Agile / Scrum teamstructure7. Experience in SQL and PLSQLwriting
QualityAssuranceOperations:
Knowledge of GxP QA best practices In depthunderstanding of the regulatory guidelines for IT systems primarilyFDA EMA MHRA and PMDA In depth understandingof 21 CFR Part 11 EU Annex 11 complianceMinimum 10 years experience of client internal and regulatoryaudits Anchor updates toQMS Engage in Continual Improvementprograms Coordinates the revision review andapproval of IT SOPs and other GxPdocuments

internal audits,21 cfr part 11,almtool based executions,manual execution,argus,qmsupdates,pmda,mhra,plsql,csv (computer system validation),regulatoryaudits,agile,mhra guidelines,qms,gxp,client, internal andregulatory audits,pmda guidelines,plsql writing,trainingcoordination,it sops review,fda guidelines,csv,eu annex 11compliance,qa best practices,sql,pharmacovigilance,regulatoryguidelines for it systems,alm tool,gxp documents approval,revision,review, and approval of it sops and other gxp documents,updates toqms,pharmacovigilance domain,fmd,qa,electronic qms/dms,scrum,emaguidelines,training coordination and management,arisg/j,agile /scrum,revision coordination,audits,continual improvementprograms,client audits,drug safetyapplications


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