Quality Specialist - Auditor
Abbott.
Dubai
منذ 6 يوم
source : Wisdom Jobs

Quality Specialist - AuditorGFH Description At Abbott we re committed to helping you live your best possible life through the power of health For more than years we ve brought new products and technologies to the world in nutrition diagnostics medical devices and branded generic pharmaceuticals that create more possibilities for more people at all stages of life Today of us are working to help people live not just longer but better in the more than countries we serve Connect with us at on Facebook atand on Twitter AbbottNews and AbbottGlobal THE POSITION The role of the Auditor function is to manage on-

site audits and Quality Questionnaires related to Suppliers Third Party Manufacturers and affiliates for GxP and Pharmacovigilance PV that fall under the responsibility of EPD QA The scope is Suppliers and Third Party Manufacturers that provide materials services and products to region EPD Suppliers can include API suppliers contract labs excipient suppliers commodity suppliers and third party manufacturers who provide intermediate final products to region EPD CORE JOB RESPONSIBILITIES Reporting to a Quality Systems and Compliance manager your key responsibilities will include Manage on site GxP and PV audit for regional and local Suppliers and Third party Manufacturers and affiliates All activities required to plan prepare for conduct report and close the assigned audits Ensure that all audit related information is documented into the Audit Tracking system in a timely manner Manage Quality Questionnaire for Suppliers affiliates and Third Party Manufacturers regionally Assess the appropriateness and timeliness of proposed CAPAs and track CAPA follow-

up to close for affiliates regional supplier and TPMs Timely information on the audits to management and stakeholders Escalation of any critical findings or negative audit outcomes to regional EPD senior management in line with the applicable policy and procedures Reviewing any Quality Questionnaires returned by the Suppliers TPMs and resolving any issues Read and extract developing regulations and trends from available sources to provide recent perspectives during audits Ensure a proactive determination of regulatory compliance and quality issues and integrate them into audits assessments on a priority basis Responsible for supporting creation and implementation of continuous improvement initiatives Actively participates on cross-

functional team projects in a structured business environment in accordance with internal procedures and external regulations Provide support to regional EPD plants affiliates and Contract Operations QA in the timely resolution of issues related to Suppliers and Third Party Manufacturers Discuss with and agree with the affiliates Suppliers and TPMs a timely implementation of corrective and preventive actions as needed to prevent recurrence POSITION ACCOUNTABILITY SCOPE The Senior Quality Specialist auditor works with guidance from the regional Quality Systems and Compliance manager Qualifications MINIMUM EXPERIENCE REQUIREMENTS At least 7 years in the Pharmaceutical Industry and or Government Regulatory Agency and at least 5 years of GXP Auditing experience with a minimum of 3 years Lead auditor experience in GxP Pharmacovigilance or ISO EDUCATION Bachelor Degree or equivalent level of education at a relevant scientific discipline or other technical scientific or industry experience with sufficient exposure to pharmaceutical or related industries ASQ Certified Quality Auditor CQA Certified Quality Engineer CQE or other international certification desirable Job Classification ExperiencedJob ACCOUNTING FINANCEPrimary Location United Arab Emirates-

Dubai-DubaiOrganization EPD-EstPharmDivSchedule Full-timeTravel Yes of the Time

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