Deviations Specialist

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeThe incumbent will provide guidance coaching and coordination for all aspects related to the initiation trackingtrendingand management of allManufacturing Investigation Reports (MIR) Corrective and Preventive Actions (CAPA) evaluation of CAPA effectiveness and Operational Excellence(OPEX) projects within Sterile Product Manufacturing (SPM) incumbent will work with theSPM managementteam and Quality Assurance(QA)tofacilitatethe consistent disciplined execution of the Event Report/Quality Assurance Report (ER/QAR)quality system ensuring the completeness and comprehension of the investigations and determination of most probable root data gathering and metricsrelatedthe tasks above will be gatheredcompiledand delivered to relevant requestors as required. Role ResponsibilitiesCompletes andfacilitatescompletion of Manufacturing Investigation efforts within SPM to ensure compliance with quality and cycle time guidance coaching and feedback to all groups involved in initiatingcompletingand conducting manufacturing investigations and CAPA and analyzes historical data toidentifytrends androot-causeof manufacturing and recommends corrective and preventive actions to prevent/eliminaterecurrent discrepancies andleadsits implementation in that QAR system requirementsM1/PHPare being executed asestablishedin the sites Standard Operating Procedures (SOP) and other as the primary contact in the resolution of conflicts and differences resulting from the resolution of in the design and deployment oftrainingsto educate employees on how to report initiate conduct and close an efforts to educate leaders and employees on OPEXmethodspracticesand process improvement initiatives that increase quality/complianceefficiencyand safety within the Sterile Product Manufacturing facilityBasic QualificationsEducation:The successful candidate will have a minimum of nine years of applicable experience and a BA/BS/MS degree in Engineering Chemistry Physical/Biological Sciences Business Integrated Supply Management or related applicable discipline that will enable the team to meet its :Effectiveteambuilding skillsProvenleadershipand change management abilitiesAbility to effectively coach and mentor colleaguesStrong oral and written communication skillsAbility to influence at all levels of the siteM1 and PHP education and experienceLean SixSigma education and experienceAbility to connect the mission of the team to site goals Green/Black belt certification is highly desired. Strong background in GMP Manufacturing QA/QC Aseptic Manufacturing and/or Environmental Monitoring is highly desirable.#LI-onsite #LI-BM1