Company

KCR

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Senior Quality Assurance Auditor | Germany

Publication

2021-09-15

Company description

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.com.

We see the human behind every number.

KCR is a clinical development solutions provider for the biotechnology and pharmaceutical industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR now operates across five regions: North America, Western Europe, Central Europe, Eastern Europe, and Australia, with a main operational hub located in Boston, MA. Our strategic hub locations, technical capabilities and solution offerings allow for the optimized delivery of trial execution strategies to develop life-changing therapies. KCR offers access to an estimated population of 1.1 Billion people. For more information visit www.kcrcro.comWe see human behind every number.

 

 

Senior Quality Assurance Auditor

 

 

Location: Germany (home-based)

 

 

Senior Quality Assurance Auditor is responsible for implementation of KCR strategies in the scope of QA in all countries of KCR as well as ensuring that quality standards of clinical research are abided by all KCR employees, contractors and subcontractors at each level.

 

 

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 KCR;
  • 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 Auditors and other Quality Assurance and Compliance Department staff.

Requirements:

 

 

  • At least 2-3 years of experience as an auditor in medical/ pharmaceutical/ medical device/ CRO field, with relevant work experience in clinical research;
  • Minimum of 3 years of GCP and GLP auditing experience in auditor role;
  • Strong experience with site and vendor audits of all kinds;
  • Previous work experience in a quality assurance role with responsibilities for SOP writing and review;
  • Experienced in oncology trials specifically;
  • Knowledge of GCP, GMP and GLP regulations;
  • 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.

 

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs. To show that you are appreciated in our team, while working at KCR you will be provided with:

 

 

  • Ability to join international CRO company and develop knowledge of clinical trials industry;
  • Possibility of development of qualifications and skills;
  • Onboarding process to enable you fast takeover of duties;
  • Peer/Buddy/Mentor who will introduce you to the organization;
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed;
  • Empowering workspace, offering opportunities to share ideas;
  • Mentoring and training programs related to clinical trials, therapeutic areas, soft skills development;
  • Additional days of for certain special occasions (including your birthday).