BrightOwl Loader Loading

Quality Assurance Manager (DE) - Germany  

KCR (company)


Posted on : 08 March 2017

Project Description

The duties associated with the role include:
  • Supervising and conducting internal and external audits 
  • Providing assistance in the area of preparation of sponsor audits and inspections 
  • Preparing reports from audits, along with suggestions of appropriate corrective actions 
  • Preparing, planning, performing and controlling the processes of CAPA implementation in response to audits (internal and external) 
  • Implementing company strategy, standards and metrics for QA activities 
  • Providing support and maintaining the organization of SOP system in our company.
  • Maintaining full knowledge of all local policies, procedures and guidelines, FDA and European (EMA) and local regulations and guidelines 
  • Providing training sessions on topics related to quality and/ or compliance as individually assigned 
  • Evaluating and developing assigned Quality Assurance and Compliance Department staff  

  • At least 3 years of experience as an auditor in medical/ pharmaceutical/ medical device/ CRO field, with relevant work experience in clinical research 
  • Very good understanding of industry standards and applicable GCP guidelines and FDA/EMA regulations 
  • Awareness of GMP and GLP regulations, basic knowledge of software validation process 
  • Ability to manage work schedule in accordance with priorities in changing environment 
  • Computer competency 
  • Fluency in English 
  • Sound judgement to evaluate discrepancies, make decisions and report findings 
  • Ability to produce quality reports and written documentation 
  • Ability to travel domestically and internationally approximately 50% of time in order to perform QA responsibilities and attend training sessions