QA Manager

Job Description

JOB DESCRIPTION:About Abbott:Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.Connect with us at www.abbott.com, on at www.linkedin.com/company/abbott-/, on Facebook at http://www.facebook.com/Abbott and on Twitter @AbbottNews.QA Manager (UAE, Kuwait, Qatar and Bahrain)Type of role-Fixed term contract role (1 year)Job Purpose-- To provide expert quality advice and support to the Abbott affiliate.- To lead any QA activities as they arise.Job Responsibilities-? Develop & maintain high standard quality systems, divisional policies/procedures and regulations related to Quality for theAffiliate.? Develop, structure and control an appropriate Quality system and Management thereof for the Affiliate.? Ensure local Affiliate QA Policies and Procedures are up-to-date in accordance with applicable external localrequirements/regulations and in accordance with Abbott?s global procedures.? Where applicable, coordinate training programs related to Affiliate Quality System education, ensuring all relevantemployees are trained & records maintained.? Ensure compliance of validation requirements for Affiliate processes, systems (including Quality related computer systems)and distribution centers. Review and approve master validation plans and validation protocols (if applicable).? Manage the Affiliate customer complaints system in compliance with divisional policies/procedures, within the designatedIT system.? Monitor status of complaints reports. Review complaint data regularly, identifying trends for continuous improvement &preventative actions.? Manage the Affiliate ER/CAPA system in compliance with divisional policies/procedures, within the designated IT system.? Provide input and assist other Functional areas regarding any QA-related activities and keep GM abreast of any practicesthat could impact Abbott?s products and/or processes.? Participate in QA projects with global QA as required.? Keep up to date with current best practice and guidelines relevant to the role.? Conduct QA internal audits & facilitate/direct all external audits/regulatory inspections.? Support Warehouse and or Distributor operation regarding all AN QA product compliance activities as required.? Provide direct QA oversight to local TPM activities including local Product finishing (e.g. over-labelling) activities ifrequired? Responsible for product release/disposition (if required locally)? Evaluates, manages and monitors quality related Supplier performance in compliance with divisional policies/procedures,within the designated IT system.Qualification/ Experience/ BackgroundMasters or PhD in pharmacy, science or medical disciplineMinimum 3 years experience in a Quality Assurance role within the Pharmaceutical industry is essential.JOB FAMILY:Operations QualityDIVISION:LOCATION:United Arab Emirates > Dubai : Ubora Tower2ADDITIONAL LOCATIONS:WORK SHIFT:StandardTRAVEL:Not specifiedMEDICAL SURVEILLANCE:Not ApplicableSIGNIFICANT WORK ACTIVITIES:Not Applicable

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