Team Lead-CSV

4 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 GxP documents

euannex 11 compliance,client, internal and regulatoryaudits,arisg/j,mhra,gxp,sql,plsql writing,training coordination andmanagement,revision, review, and approval of it sops and other gxpdocuments,electronic qms/dms,pmda,agile / scrum,csv,updates toqms,manual execution,argus,alm tool based executions,csv (computersystem validation),pharmacovigilance,regulatory guidelines for itsystems,qa best practices,qa,fmd,drug safety applications,continualimprovement programs,21 cfr part 11


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