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Quality Assurance Auditor (m/f) - Austria  

Celerion (company)


Posted on : 09 April 2017

Project Description

  • Our company  is the leading global provider of outsourced early clinical research services.
  •  Customers include the leading global pharmaceutical companies as well as a number of biotechnology and small to mid sized pharmaceutical companies.   
  • Our focus is on the development of innovative pharmaceuticals with the goal of enabling companies to reach early decisions concerning which compounds to progress further into clinical development.  
  • Our company  provides these services through three clinical research units with over 600 beds located in the US and Europe. 
  • In addition,our company provides clinical research services through partnerships with other clinical research units in North America, Europe and Asia. 
  •  Supporting our clinical work are two world class bio analytical laboratories located in Europe and the US.  
  • Our company is unique from other leading CROs in that our sole focus is on first-in-man studies to clinical proof-of-concept, as well as clinical pharmacology studies to support product labeling, in contrast to other leading CROs who provide services from discovery to the market.

Services include:  
  • Early Clinical Research and studies required to support product labeling 
  • Data Management and Biometrics (modeling and simulation, study design and protocol development, clinical data management, biostatistics, PK/PD, medical writing and reporting) 
  • Bioanalytical Services (discovery to late stage services with capabilities in small and large drug, metabolite and biomarker molecules) 
  • Drug Development Services (Regulatory affairs and drug development consultancy) 
  • Global Clinical Development including global multi-site studies conducted outside of company  clinics 

Quality Assurance Auditor (m/f)
The Quality Assurance Auditor (QA Auditor) will assess and assure study, project, and process compliance with protocols, company Standard Operating Procedures, and applicable regulations and guidelines through audits. Additionally, he/she will assist Process and Standards Management with Standard Operating Procedures review, documentation and training records. The area of Auditing is Good Clinical Practice.

Essential Functions:
Day-to-day Quality Assurance Activities: 
  • Carry out auditing of Line of Service (LOS)  (Global Clinical Development (GCD) is a clinical operations department) study procedures, data, records and documentation to assure compliance with study protocols, procedures, and applicable regulatory requirements (laws and industry standards) and guidelines; report audit findings via QA audit reports; and determine acceptability of the responses and verify the corrections/corrective actions. 
  • Perform system audits and audits of study phases; report audit findings via QA audit reports; determine acceptability of the responses and verify the corrections/corrective actions. 
  • Review study conduct issues, deviations, investigations, and change control documentation; and assess acceptability of the content and documentation. 
  • Maintain QA files and QA audit reports. 
  • Interact with internal clients to discuss QA observations and study related issues; and maintain effective and professional working relationships within and across departments in relation to study projects. 
  • Perform other functions as assigned by quality management. 
  • Providing consultancy on Quality Management System(QMS) and Good Practice (GxP) topics 

Quality Management System: 
  • Participate in the improvement initiatives intended to improve quality, compliance of study, project data and reports; effectiveness and efficiency of the processes. 
  • Detect Quality Issues and need for CAPAs, and assist quality management with the QI/CAPA process. 
  • Participate in the review and/or writing of SOPs and other controlled documents, as required 
  • Update/maintenance of company SOP binders and training records 

Client/Sponsor Audits and Regulatory Authority Inspections: 
  • Assist with the preparation for and hosting of client/sponsor audits and/or regulatory inspections. 

Facility Based Audits (internal): 
  • Participate in the preparation and execution of internal Facility based audits. 
  • Assist in vendor management through conducting QA audits of current and potential vendors via questionnaires and remote auditing. 

  • Bachelor’s degree in science or similar 
  • 1 - 5 years quality experience 
  • 4+ years of pharmaceutical/device clinical research experience 
  • Working knowledge of applicable Line of Service (LOS) (GCD)/function regulations and guidances (GCP/cGLP/cGMP and 21CFRPart 11, regulations and related guidelines, as well as local regulatory authority regulations as required. 
  • Excellent oral and written communication skills in English and German; knowledge of other languages advantageous 
  • Ability to organize and manage multiple priorities 
  • Good time management skills 
  • Collaborative team player, open minded, ethical and culturally sensitive 
  • Adapts well to change, decisive, tenacious and versatile 
  • Logical, observant, perceptive and good listening skills 
  • Attention to detail, tactful, and diplomatic 
  • Computer literate 
  • Flexible and willing to travel on occasion