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Senior QA Auditor - Quality & Compliance

Dublin
Permanent
Reference: 055820
This vacancy has now expired.
Description

Senior Auditor, Quality and Compliance

Location: Leopardstown, Dublin 18

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

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. 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 an expert Quality and Compliance Senior Auditor to join the team in our global HQ in Leopardstown, Dublin 18.

The Role

As a Senior Auditor within Quality and Compliance and reporting to a senior manager within the team, you will be responsible for performing tasks relevant to the assigned Quality & Compliance (Q&C) function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defence, case management and CAPA management.

There is travel of up to 35% involved with this role.

  • Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defence, case management and CAPA management.
  • 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.
  • 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.
  • 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, and appropriate regulations and guidelines.
  • Understand key business drivers; uses this understanding to accomplish own work

What you need

  • A degree in life sciences
  • Experience in Pharmaceutical and/or GXP environment including in-depth knowledge and experience in Quality Assurance auditing and/or with relevant regulatory compliance /Quality System , including quality system development and leading system development projects.
  • Ability to review and evaluate clinical data/records/systems/processes and make improvement recommendations.
  • Thorough knowledge of the clinical development process
  • Thorough knowledge and experience in performing and leading Root Cause Analysis.
  • Ability to manage complex issues and related CAPAs, including leading large cross functional teams, task prioritization, and project management as needed.
  • A super team player who is happy to support junior members of the team
  • Excellent communication and relationship building skills

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 Auditor, Quality and Compliance, 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.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin

 

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