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18.11.2021

Quality Assurance

We are looking for an employee to reinforce our team as

Location: Vienna / 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
      • Update of the Validation Master Plan (VMP) and Master Schedules
      • Securing the validity of the test results through appropriate QA measures
      • Monitoring the GxP conformity of all laboratory activities
      • Check for completeness and GxP-compliant execution of the relevant analysis documentation including accompanying documents
      • Archiving of GMP and GCLP relevant documents
      • Supplier Management/Qualification
      • Establishment and update of appropriate hygiene program
      • Participation in internal and external audits
      • Management of change control, deviations and CAPAs
      • Audit trail review

 

Requirements:

      • 3 years of related experience in the pharmaceutical industry or health authority
      • Experience in a GMP Quality Assurance department
      • Knowledge of cGMP requirements
      • Experience with Equipment Qualification
      • Experience with Computerized System Validation
      • Excellent, demonstrated verbal and written communication skills in English and German
      • Proficient with MS Office applications
      • Excellent organizational and communication skills and detail-oriented

 

Bonus: GLP experience


What we offer

      • 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

 

We offer an interesting opportunity for a motivated positive thinking person. You can expect an annual salary of €40.000 and guarantee overpayment for professional experience or above-average qualifications.

 

VelaLabs GmbH
Human Resources
Brunner Strasse 69/3
A-1230 Vienna
+4369913143124
E-Mail: jobs@vela-labs.at – Betreff: “Quality Assurance Assistance 03”

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