28 days agoErnst & Young

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.