Senior Auditor, QA
ICON
Bucharest
‎în urmă cu 18 ore

Location : Europe

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role :

  • Perform tasks relevant to the assigned Quality & Compliance function which may include but not limited to conducting contracted / internal, documentation review and CAPA management.
  • Conduct ICON staff training regarding ICON's quality system, Q&C tasks & processes, applicable standards, regulations;
  • mentor new or developing Q&C staff as assigned, including providing constructive and effective feedback to trainees regarding skill capabilities during training.

  • Escalate quality and compliance issues to Q&C Line Management and relevant ICON functions as appropriate.
  • Delegate assignments to local Q&C audit staff at the request of Q&C management; provides support and escalates for intervention to ensure staff have the necessary tools to perform requested assignments.
  • Liaise with clients and operational staff on quality aspects which may include attendance at meetings, oral presentations and audits.
  • Assist with business development activities, including the preparation of contracted audit cost proposals / contracts, and attend marketing presentation, when appropriate.
  • Have a thorough knowledge of all relevant SOPs, with ICH-GCP and relevant regulations and guidelines.
  • AUDITING Responsibilities :

    Plan and conduct regular contracted audits (including standalone work), for cause audits, vendor and sub-contractor audits.

  • Report the results of the audit and any relevant findings and track them into the ICON systems as requested.
  • Review audit responses by the auditees. Follow up all outstanding replies and escalate issues to the relevant management for action.
  • Assist the Q&C management with the development of the internal audit schedule.
  • Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.
  • Operates under moderate supervision and direction and makes decisions frequently that have a direct impact upon the local external and internal audit schedule and the resource allocation for audits within the local department.
  • CAPA MANAGEMENT Responsibilities :

  • Lead investigations, root cause analysis (RCA) and resulting CAPA management for ICON Quality Issues.
  • Ensure that the ICON's QMS / tracking system is updates with the appropriate information of documentation
  • Follow-up of CAPA plans to ensure actions are completed on time and the evidences available are adequate.
  • Determine effectiveness check requirements for responsible CAPA, define the effectiveness check plan, track and complete the effectiveness checks as required, determine the outcome and inform operations and Q&C management accordingly.
  • Assist with the review of effectiveness check plans and effectiveness check outcomes for more junior QA auditors.
  • Assist Q&C Management / Director with oversight of open CAPAs, trending and analysis of CAPAs and metrics reporting. This includes providing summary information / input to Governance reports.
  • Support ICON functions and client for regulatory reporting such as regulatory reporting documentation as needed..
  • What you will need :

  • At least 2-3 years experience as QA auditor in GCP and / or pharmaceutical environment, including in-depth knowledge of GCP audits (e.
  • g. investigator site audits, trial master file audits, and other GCP audit types) for clinical trials phase II / III with relevant regulatory compliance / Quality System,

  • Knowledge of relevant GxP regulations as applicable to the QA function
  • Good understanding of drug development and clinical trial process
  • Ability to review and evaluate clinical data / records / systesm / processes
  • Knowledge and experience in performing and leading root cause analysis
  • Well-developed interpersonal and communication skills (oral and written) with prior experience conducting presentations or facilitating meetings
  • English fluency (oral / written) to conduct onsite and remote GCP audits in English language,
  • Competent computer skills including MS office applications (Outlook / Word / Excel / Powerpoint),
  • Ability / willingness to travel,
  • University / bachelors degree / diploma in life sciences or local equivalent qualification / relevant work experience.
  • Knowledge in electronic clinical trial systems ( e.g. CAPA mgt. systems such as Trackwise, electr. Trial Master File systems, Clinical Trial Management Systems etc) is definitely a plus but not a must.

    Benefits of Working in ICON :

    Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture -one where we challenge you with engaging work and where every experience adds to your professional development.

    At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.

    In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career -both now, and into the future.

    ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.

    All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

    If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

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