Compliance Specialist

Greetings from HCLHiring for "Compliance - QMS"Experience - 4- 14 yearsNotice period - Immediate to 90 daysCTC- Open for discussionLocation - Bangalore / Chennai / Noida / Pune / HyderabadJD;Stakeholder ManagementExcellent Oral and Written communication.Extensive experience in directly working with customersPeriodic ReviewHands on experience in conducting Application Periodic ReviewsManage Periodic review processes including scheduling, conducting and reporting of Periodic reviewsDocumenting process gaps and working with stakeholders to rectify themExperience in analyzing risks and working with stakeholders for mitigationsDeviationPerforms Deviation Creator role and maintains the Deviation lifecycle and creates identified Deviations as a Deviation record in QMS systemCollaborates with multiple stakeholders in recording, managing deviationSupports as required in Route Cause Analysis (RCA) process using QMS specified method to manage DeviationEnsures Deviations are linked to CAPA and Effectiveness CheckAbility to communicate and manage multiple stakeholders across different spectrumCAPAAdept in using CAPA management module using TrackWise or any eQMS systemCreates requests for “Due Date Extension” or “Cancellation” requests for CAPA as per the stakeholder requestTracks all CAPA, Deviations to closure without any timeline deviationsProvides trend analysis of CAPA to identify patterns and to measure effectiveness checkProactively escalates necessary communications to ensure CAPA is timely managedProactively communicates and excels in stakeholder managementSupplier AssessmentsExtensive knowledge and experience in conducting supplier assessmentsInterested candidates please drop an email to " "Regards,Kushma