Eastwood, New South Wales, Australia
21 hours ago
Senior QA Manager
About Abbott
 Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
 Working at Abbott
 At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:Career development with an international company where you can grow the career you dream of .Amazing health and wellness benefits and perks.A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientistsThe role works for Abbott nutrition. Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna®  – to help get the nutrients they need to live their healthiest life.The Opportunity To manage Quality Assurance operations within the Affiliate for ANI. To monitor and ensure release for sale of product conforming to Abbott quality requirements. This role also supports continuous improvement activities and continued compliance to ISO9001 certified Quality System, applicable post market regulatory requirements and key internal divisional quality related policies and procedures. The role also includes the management of pump centre in country.Main responsibilitiesMonitor and ensure release for sale of all products which conform to Abbott and local regulatory requirements and specifications.Manage the operations of the pump center team to ensure that the pumps are in working conditions before dispatching to customersManagement of distributors in Australia and New ZealandManagement of customer complaints processCo-ordinate and implement product field actions (recalls, safety alerts etc)Ensure Quality Systems are in place that meet AN quality requirement includes CAPA, supplier management etc.Provide guidance and advice, as requested, on the development and implementation of quality systems.Facilitate to ensure Quality management of Distributors per request.Take charge of internal/ external QA relevant auditingMaintain or ensure QA documentation in place.Develop and maintain Quality System related SOP.Lead Management review meetingEducation Bachelor of Science in Pharmacy/Science/Engineering.EXPERIENCE /QUALIFICATIONMinimum of 10 years of experience in Quality Assurance and /or Compliance in a regulated industry.Minimum of 3 years supervisory / managerial experience .Ability to effectively communicate in EnglishStrong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners.Ability to negotiate with stakeholders.Able to manage multiple priorities and pull information together from multiple business units to ensure concise consolidated business picture is communicated to the commercial businesses.Experience in conducting and handling audits
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