Company

KCR

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Senior Quality Assurance Auditor (PL, DE, UA)

City/voivodeship

Warsaw (woj. mazowieckie)
Berlin (woj. zagranica)

Publication

2019-09-06

Company description

KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, 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.
KCR: We see human behind every number
KCR is a clinical development solutions provider for the biotechnology, pharmaceutical, and medical device industries. We support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, 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. 
KCR: We see human behind every number.
Location: Warsaw, Kiev or Berlin (office-based)
 
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
  • 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: 
  • 3-step onboarding process to enable you fast takeover of duties
  • Peer Buddy Mentor who will introduce you to the organization
  • Flexible, remote working options
  • Time off – additional days of holidays for birthday, leaves of absence
  • Loyalty bonus for long term cooperation
  • Employee referral program
  • Empowering workspace, offering opportunities to share ideas and influence company services development worldwide
  • Open culture based on our values: learning, customer focus, accountability, commitment, tenacity and determination to succeed
  • Mentoring and training programs related with clinical trials, therapeutic areas, soft skills development
If you wish to apply, please submit your CV using the button below.