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.
activities as per GAMP Life Cycle approach
Management System etc.
consultation with relevant functions.
validation policies is in line with Life Cycle Approach
engagements byassociating with clients and executing the deliverables in the most efficient
& contributes to thought leadership documents.
completing the deliverables within the timelines
developments and newpronouncements/standards relevant to the client's business.
•Activelycontribute to improving operational efficiencyon projects & internal initiatives.
•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
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
in Pharmaceutical organization.
• Versed with SOP documentation, analyzing the work instructions, user manuals
Controls etc. as theyrelate to Computer Systems
• Basic understanding of Data Integrityrequirements
Management, QualityManagement Reviewprocedures.
• Experience in supporting Audits / Inspections would be add-on
• B.E/B.Tech (Electronics, Electronics & Telecommunications, Comp. Science)/Post graduate in
Multi-National Life Sciences companies
• Good interpersonal skills;Goodwritten and presentational skills
• Certified Software QualityEngineer (CSQE), Certified Software Quality Assurance (CSQA)
• Information Securityor Risk Management certificationswould be add-ons.