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.
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.