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Senior Auditor, Quality Assurance

  1. Sofia, Warsaw
JR120077
  1. Quality Assurance
  2. ICON Full Service & Corporate Support
  3. Hybrid: Office/Remote

About the role

Role : Auditor, Quality Assurance

This role will be based in one of the countries listed

GCP experience is mandatory for this role

At ICON, it’s our people that set us apart.

As a global provider of drug development solutions, with our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for a Senior QA, Auditor to join the team in the Poland or Bulgaria.

The Role:

  • Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting internal/contracted and vendor audits and CAPA management.

  • 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 persons including managers on quality aspects which may include attendance at meetings, oral presentations and audits.

  • Have a thorough knowledge of all relevant SOPs, and appropriate regulations and guidelines.  Understand key business drivers; uses this understanding to accomplish own work.

  • Build knowledge of the company, processes and customers.

  • Conduct departmental and 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.

  • Assume additional responsibilities, which are directed by the Q&C Manager or higher.

  • Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.

  • As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs.

  • Travel (up to 35%) domestic and/or international, on occasion this may increase based on business needs.  Depending on Q&C function, an Auditor may be requested to complete all/some of the responsibilities listed below under each heading as needed.  

AUDITING Responsibilities:  

  • Plan and conduct regular internal audits (Investigator site, TMF and monitoring related audits etc..) as well as contract audits (including standalone work) and for cause  audits  of  the  ICON  quality  system  in  order  to  evaluate  the  quality  system  against  the requirements appropriate regulations and applicable guidelines.

  • Perform the role of a lead auditor to assess the effectiveness of the quality system and to verify that the quality system is being implemented.

  • Perform vendor and sub-contractor audits and follow up of previous findings.

  • Review audit replies to Q&C. Follow up all outstanding replies and report issues to the relevant management for action.  

  • Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.

  • Assist with the development of the project audit schedule.

  • Verification of audit CAPA completion where required by procedure.

  • Train QA auditors, and provide a standard for auditing to inexperienced or less experienced colleagues.  

  • Carry out a senior role in the regional QA department (Project Audits), such as scheduling of audits.  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.  

What you will need:

  • Background in medicine, science and/or other relevant discipline and appropriate experience.

  • Must have 2 years experience within QA auditing

  • Thorough knowledge of GCP Guidelines and relevant regulations for the conduct of clinical trials.

  • Knowledge of CAPA management, including performing effective root cause analysis

  • Experience in regulatory authority inspections an advantage

  • Ability to review and evaluate clinical data / records.

  • Excellent communication and interpersonal skills, including the ability to liaise successfully with project teams, investigators and clients.

  • Detailed understanding of drug development and clinical trial process.

  • Good problem resolution skills.

  • Good planning and organizational skills with the ability to multi-task and prioritize effectively.

  • Ability to work efficiently and independently under pressure.

Why join us?

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Senior QA Auditor, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

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