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19.04.2022

Quality Assurance Officer (f/m/d)

Location: Wien / Austria

VelaLabs is an international, innovative contract laboratory offering analytical services for Biologics (ATMPs, Biopharmaceuticals, Originator products, Biosimilar Candidates / Biosimilars, Blood and blood components, Vaccines) Chemicals and Excipients from early stages of product development (non-clinical, clinical) until market release testing. The company is GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA.

Responsibilities

      • Creation, maintenance and continuous improvement of a GxP-compliant Quality Assurance system including e.g. document management, deviations, change control, CAPA, risk analysis, qualifications, validations
      • Securing the validity of analytical performance through appropriate QA measures
      • Monitoring the GxP conformity of all laboratory activities
      • Supplier Management/Qualification
      • Participation in internal and external audits
      • Participation in Audit trail review
      • Participation in risk management
      • Training management
      • Participation in Equipment Qualification/Computerized System Validation

    Requirements:

        • Experience in the pharmaceutical industry or health authority
        • Experience in a GMP Quality Assurance department
        • Knowledge of cGMP requirements
        • Experience with Equipment Qualification, Validation
        • Experience with Computerized System Validation
        • Good, demonstrated verbal and written communication skills in English and German
        • Proficient with MS Office applications
        • Good organizational and communication skills and detail-oriented
        • Positive thinking, team minded person with risked based mode of operation

    Bonus:

        • GLP experience
        • Six Sigma and Lean experience

      What you can expect

          • Diverse creative environment and problem-solving atmosphere with a highly motivated team.
          • Flexible working time
          • Parking place in front of the company or public traffic ticket for Vienna
          • You can expect an annual salary of €35.000 and guarantee overpayment for professional experience or above-average qualifications

       


      We offer an interesting opportunity for a motivated positive thinking person.

      Gender, age, ethnicity, sexual orientation and disability are irrelevant, we support diversity.

       

      Please send your application to:

      VelaLabs GmbH
      z.H. Human Resources
      Brunner Strasse 69/3
      A-1230 Wien
      +4369913143124
      per Mail jobs@vela-labs.at – “Quality Assurance 08”

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