Company

KCR

Advertisement

Quality Assurance Associate (DE,US,UA)

City/voivodeship

Berlin, Boston, Kiev

Publication

2018-11-16

Company description

KCR is a contract research organization providing clinical development solutions for the pharmaceutical, biotechnology and medical device industries.
The company supports clients with full-service capabilities across three main services: Trial Execution (TE), Functional Service Provision (FS) and Trial Execution Consulting (TC) over a broad range of therapeutic areas. 
KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe with hubs located in Boston, U.S., Berlin, Germany, Warsaw, Poland and Kiev, Ukraine. KCR’s geographical locations allow for optimized delivery of trial execution strategies to develop life-changing therapies. For more information visit www.kcrcro.com.
KCR: We see human behind every number
A leading Contract Research Organization (CRO), with over 20 years of presence on the international market, operating across 27 countries is seeking to employ Quality Compliance Associate. The role will focus on ensuring compliance with applicable regulations, SOPs and standards across KCR. This is an exceptional opportunity for professionals who feel comfortable in translation of processes to procedures, enjoy high-volume cross-departmental communication, stay abreast of relevant regulations and who present impeccable English language skills. This is a permament position in one of the company's Operational Hubs.
Location: Berlin/Boston/Kiev (office-based)

The duties associated with the role include:
  • Support in ensuring company compliance (documentation and process compliance) with applicable regulations, SOPs, good practice standards,
  • Being up-to-date with regards to GXP (GCP, GMP, GDP) regulations/guidelines – maintenance of quality knowledge database,
  • Support in SOP writing and improvements (cooperation with other departments to increase the quality and consistency of KCR SOPs) - verification of SOP framework in order to identify and correct process gaps, discrepancies, inconsistencies in cooperation with applicable Functional Area Leads and Quality Assurance Team,
  • Provide support in maintenance and further development of KCR SOP and CAPA systems (support in improving quality tools, trackers and metrics), keeping quality tools and trackers up to date, preparing of quality status reports,
  • Providing support to Quality Assurance Auditors in audit preparation and follow-up activities  (audit scheduling, collection and filing of audit documentation, audit follow-up communication),
  • Reporting to Quality Assurance Manager

Requirements:
  • Experience in a clinical research environment with strong working knowledge of ICH-GCP regulations
  • 1-2 years of engagement in quality assurance activities (CRO or Pharma GxP exposure)
  • Fluent command of English
  • Very good work management, ability to set priorities
  • Proactivity and self-motivation
  • Attention to details when working on different projects 


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
  •  Friendly office space, coffee, tea and sweets
  •  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: knowledge, 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.