Junior Quality Specialist Diagnostics (maternity cover)
Bucharest, Romania
5 zile în urmă

For our Abbott Diagnostics Division ADD we are looking for a highly motivated, ambitious professional to join our team in Bucharest, Romania as a Junior Quality Specialist.

This will be a fixed-term, maternity cover position and will report directly to the RegionalQAManager based in Poland.

Primary objective and impact of the role :

  • SupportsQuality System compliancein a specific region or regions.
  • Supports a specific process or processes for the whole Europe / EEMEAP as Subject Matter Expert (SME), its backup, or part of the team
  • Operates under Quality and Regulatory directives and Abbottpolicies and procedures.
  • Follows local regulations and international industry / Quality Systemstandards
  • Key responsibilities :

  • Supports the ManagerQARegion to ensure Europe / EEMEAP and RegionQuality Systemeffectiveness and compliance
  • Performs internal andsupplier audits.
  • Supports / prepares / coordinates external audits.
  • Review & approve locally developed AdPromo material in local language on behalf ofRegulatory Affairs
  • Supports the Europe / EEMEAP commonQuality Systemand QS processes : e.g. Field communications,supplier evaluation, audits andCAPA, AdPromo,document controland record keeping.
  • Review Abbott policies & procedures, and update Quality documentation accordingly.
  • Manage any audit input by initiating changes to affected processes following MIMSchange controlprocedures.
  • Translates documents RO / ENG and ENG / RO.
  • Requirements :

  • Scientific background (i.e. Lab Technician, Biology,Chemistry, Pharma, M.D.,Engineer) preferred.
  • Prior relevant experience inQA, RA within diagnostics,medical devicesor pharmacy is highly desirable (min. 1 year)
  • Quality Assurance in a commercial affiliate at the diagnostic / medical device / pharmaceutical industry is preferred.
  • Native or bilingual level of Romanian language is a must.
  • Excellent command of written and spokenEnglish is amust.
  • Readiness to travel (approx. 10% of time).
  • Experience to work in international environment / projects is preferred.
  • How we will reward you

    As you’d expect from a global healthcare company, we offer stable employment conditions, long-term career perspectives and a fantastic range of benefits including competitive salaries and bonus potential, a superb defined contribution pension scheme, private healthcare, life assurance and a flexible benefits scheme.

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