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04.08.2022

Quality Control

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.

We are GMP & GLP-certified, G(C)LP-compliant and is listed at the US-FDA.

Responsibilities

      • Generation of Qualification Plans, Protocols and Reports
      • Support of different Equipment and Systems owners by providing technical knowledge.
      • Planning and execution of the qualification of equipment and systems together with the equipment owner, supporting contractors and vendors
      • Carying-out risk analysis of equipment and systems independently
      • Generation and updating of Standard Operating Procedures based on internal and external guidelines
      • Participation in planning and execution of Computerized Systems Validation (CSV)
      • Support in case of change control -, deviation- and CAPA processes
      • Training of equipment and system related topics

    Requirements:

        • Experience in the pharmaceutical industry or health authority
        • Knowledge of GMP and ICH guidelines
        • 3 years of experience with Equipment Qualification
        • Knowledge of Computerized System Validation
        • Experience in change control -, deviation- and CAPA management
        • Fluent in written and spoken German and English
        • Proficient with MS Office applications
        • You are a pro-active, positive thinking team player who is detail-oriented and you have good organizational and communication skills

    Bonus:

        • Experience in a GMP Quality Assurance department
        • GLP experience
        • Six Sigma and Lean experience
        • SAP knowledge

      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 €42.000 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 Control 11”

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