Risk_Risk Transformation_Regulatory Compliance_Staff 3_BLR
Bangalore (Bangalore Urban) IT development
Job description
ob Summary
AsaLifeSciencesQuality&Compliance(Q&C)Staff,you’llactivelyestablish,maintainand strengthen internal and external relationships. With the guidance of Seniors, Managers, Directors and Partners,you’ll executecritical projects for Life Sciences clients.
Youwillactivelycontribute toimproving operational efficiencyonprojectsand internalinitiatives.In line withour commitmenttoquality,you’llconsistentlydriveprojectstocompletionandconfirmthat workisofhighquality.Whenworkingonengagements,you’llreporttohigherlevelsofmanagement, who will expectyou to anticipate and identifyrisks, and raise anyissues with them as appropriate. YouwillberesponsibleforoverallclientservicequalitydeliveryinaccordancewithEYquality guidelines&methodologies.Establishing,strengtheningandnurturingrelationshipswithclients (functional heads & keyinfluencers) and internallyacross service lines and proactivelywill also be a part ofyour day-to-dayactivities. You will assist in developing new methodologies and internal initiatives and help in creating a positive learning culture.In linewith EY’s commitment to quality, you’llconfirmthatworkisofthehighestqualityasperEY’squalitystandards,byreviewingthework provided byjunior member.
Client responsibilities
•ActivelycontributetotheITapplicationsprojectmanagementinitiativesthatincludesValidation
activities as per GAMP Life Cycle approach
• IntegratetechnologywithbusinessprocesstransformationprogramslikeSAP,LIMS,ELN,
MES,Documentum,TrackWise,VeevaVault,ValGenesis,Argus,RegulatoryInformation
Management System etc.
•TroubleshootITapplicationrelatedissuesandsuggestrecommendationsforsolutionsin
consultation with relevant functions.
•PerformGapassessmentandRemediationproceduresforlegacyapplicationstoensure
validation policies is in line with Life Cycle Approach
•PerformSoftwareclassification,ITriskassessmentandMitigationstrategiesforIT
applications.
•AssistSeniors,Managersindrivingthebusinessdevelopmentprocessonexistingclient
engagements byassociating with clients and executing the deliverables in the most efficient
manner.
•Createinnovativeinsightsforclients,adaptsmethods&practicestofitoperationalteamneeds
& contributes to thought leadership documents.
•Demonstrateteamworkbyworkingwithcrossfunctionalteamsacrossservicelinesin
completing the deliverables within the timelines
•Maintainastrongclientfocusbyeffectivelyservingclientneedsanddevelopingproductive
workingrelationshipswithclientpersonnel.Stayabreastofcurrentbusinessandeconomic
developments and newpronouncements/standards relevant to the client's business.
•Activelycontribute to improving operational efficiencyon projects & internal initiatives.
•Demonstrateadetailedknowledgeof markettrends,competitoractivities,EYproductsand
service lines.
People responsibilities
•Foster teamwork and a positive learning culture
•Understand and followworkplace policies and procedures
•Participate in the organization-wide people initiatives
•Get cross skilled and cross
Technical skills requirements
• Quality& Compliance managed services and advisory experience in of Life Sciences Domain. • DomainknowledgeinPharmaceuticalindustryintheareasofQualitycontrol,Qualityassurance • Strong knowledgeof ComputerizedSystems validation concepts such as GAMP 5-A Risk-
Based Approach to Compliant GxP Computerized Systems
• HandsonexperienceonauthoringandreviewofValidationDeliverablessuchasValidation
Plan&report,Requirementspecifications,RiskAnalysis,QualificationProtocols&reports,Test
Scripts, Traceability Matrix etc.
• Basic knowledge of standards such as USFDA 21 CFR Part 11, EU GMP Annex 11,
• Basic knowledge of regulations such as USFDA,WHO,HIPAA, TGA, MCC, Anvisa etc.
• Versedwith ICH guidelines, ISPE framework on Risk management, System Development Life
Cycle concepts.
• BasicKnowledgeonEnterpriseITapplicationslikeLIMS,SAP,ELN,MES,Documentum,
TrackWise,VeevaVault,ValGenesis,Argus,RegulatoryInformationManagementSystemetc.
in Pharmaceutical organization.
• Versed with SOP documentation, analyzing the work instructions, user manuals
• HandsonexperienceofQualitySystemElementssuchas,Deviation,CAPA,andChange
Controls etc. as theyrelate to Computer Systems
• Basic understanding of Data Integrityrequirements
• BasicKnowledgeofIncidentManagement,ChangeManagement,PeriodicReview,Vendor
Management, QualityManagement Reviewprocedures.
• Experience in supporting Audits / Inspections would be add-on
• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Post graduate in
Science(PreferablyinChemistry/Bio-Chemistry)with3-5yearsofexperiencewithBig4or
Multi-National Life Sciences companies
• Good interpersonal skills;Goodwritten and presentational skills
Certifications (desirable)
• Certified Software QualityEngineer (CSQE), Certified Software Quality Assurance (CSQA)
• Information Securityor Risk Management certificationswould be add-ons.