Senior QA Auditor

ICON plc (Salzburg, Österreich) Vor 17 Tagen veröffentlicht

Why not sign up to our job alerts so we can send jobs straight to your inbox!

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 a Senior QA, Auditor to join the team in the UK.

*Must have 3 years experience within QA auditing

The Role:

  • Perform tasks relevant to the assigned Quality & Compliance function including but not limited to conducting internal and vendor audits, Regulatory/Sponsor inspection/audit defense, case management 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.
  • Assist with business development activities, including the preparation of contracted audit cost proposals/contracts, and attend marketing presentation, when appropriate.
  • 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 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, as well as validation reviews as required.
  • 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 3 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
  • Knowledge of medical Device (MDDR) 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 planning and organizational skills with the ability to multi-task and prioritize effectively.
  • Ability to work efficiently and independently under pressure.

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.

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

Click here to see other roles I'm currently recruiting for.

Save & Close

Accept all

No, Manage

Strictly necessary

Performance

Targeting

Functionality

Strictly necessary

Performance

Targeting

Functionality

Name

Domain

Expiration

Description

CookieScriptConsent .careers.iconplc.com 1 month This cookie is used by Cookie-Script.com service to remember visitor cookie consent preferences. It is necessary for Cookie-Script.com cookie banner to work properly.

ASP.NET_SessionId careers.iconplc.com Session General purpose platform session cookie, used by sites written with Miscrosoft .NET based technologies. Usually used to maintain an anonymised user session by the server.

Name

Domain

Expiration

Description

FourmatDeviceCookie careers.iconplc.com Session This cookie detects your device type supplied by your browser user agent and will allow the website to provide the optimum browser experience for your device.

_hjTLDTest .iconplc.com Session This cookie is stored when a Hotjar script executes to try determine the most generic cookie path Hotjar should use, instead of the page hostname. This is done so that cookies can be shared across subdomains (where applicable). To determine this, we try to store the _hjTLDTest cookie for different URL substring alternatives until it fails. After this check, the cookie is removed.

_hjid .iconplc.com 1 year Hotjar cookie that is set when the customer first lands on a page with the Hotjar script. It is used to persist the Hotjar User ID, unique to that site on the browser. This ensures that behavior in subsequent visits to the same site will be attributed to the same user ID.

_ga .iconplc.com 2 years This cookie name is associated with Google Universal Analytics - which is a significant update to Google's more commonly used analytics service. This cookie is used to distinguish unique users by assigning a randomly generated number as a client identifier. It is included in each page request in a site and used to calculate visitor, session and campaign data for the sites analytics reports. By default it is set to expire after 2 years, although this is customisable by website owners.

_gid .iconplc.com 1 day This cookie name is associated with Google Analytics. It is used by gtag.js and analytics.js scripts and according to Google Analytics this cookie is used to distinguish users.

_gat .iconplc.com 1 minute This cookie name is associated with Google Universal Analytics, according to documentation it is used to throttle the request rate - limiting the collection of data on high traffic sites. It expires after 10 minutes.

_hjIncludedInPageviewSample careers.iconplc.com 2 minutes This cookie is set to let Hotjar know whether that visitor is included in the data sampling defined by your site's pageview limit.

_hjAbsoluteSessionInProgress .iconplc.com 30 minutes This cookie is used to detect the first pageview session of a user. This is a True/False flag set by the cookie.

AWSELBCORS www.iconplc.com Session This cookie name is associated with the Amazon Web Services Elastic Load Balancing functionality for routing client request on the server.

_ga .brightcove.net 2 years This cookie name is associated with Google Universal Analytics - which is a significant update to Google's more commonly used analytics service. This cookie is used to distinguish unique users by assigning a randomly generated number as a client identifier. It is included in each page request in a site and used to calculate visitor, session and campaign data for the sites analytics reports. By default it is set to expire after 2 years, although this is customisable by website owners.

_gid .brightcove.net 1 day This cookie name is associated with Google Analytics. It is used by gtag.js and analytics.js scripts and according to Google Analytics this cookie is used to distinguish users.

_gat_gaTracker .brightcove.net 1 minute This is a Google Analytics Cookie

Name

Domain

Expiration

Description

wisepops .iconplc.com 2 years Wisepops is a popup solution used by this website allows the website to display targeted modals. This is a 1st party cookie that stores various persistent data (the popups the visitor has seen / converted, A/B testing IDs, etc.).

wisepops_visits .iconplc.com 2 years Wisepops is a popup solution used by this website allows the website to display targeted modals. This is a 1st party persistent cookie where your visit dates are stored.

wisepops_session .iconplc.com Session Wisepops is a popup solution used by this website allows the website to display targeted modals. This is a 1st party cookie that stores data that has a TTL of 2 hours / browser session (initial referrer, UTM params, popups seen during the session, etc.)

VISITOR_INFO1_LIVE .youtube.com 6 months This cookie is set by Youtube to keep track of user preferences for Youtube videos embedded in sites;it can also determine whether the website visitor is using the new or old version of the Youtube interface.

GPS .youtube.com 30 minutes YouTube is a Google owned platform for hosting and sharing videos. YouTube collects user data through videos embedded in websites, which is aggregated with profile data from other Google services in order to display targeted advertising to web visitors across a broad range of their own and other websites.

YSC .youtube.com Session This cookie is set by YouTube to track views of embedded videos.

IDE .doubleclick.net 1 year This cookie carries out information about how the end user uses the website and any advertising that the end user may have seen before visiting the said website.

NID .google.com 6 months 3 days This cookie is set by DoubleClick (which is owned by Google) to help build a profile of your interests and show you relevant ads on other sites.

Name

Domain

Expiration

Description

lang cdn.syndication.twimg.com Session There are many different types of cookies associated with this name, and a more detailed look at how it is used on a particular website is generally recommended. However, in most cases it will likely be used to store language preferences, potentially to serve up content in the stored language.

AWSELB www.iconplc.com Session This cookie name is associated with the Amazon Web Services Elastic Load Balancing functionality for routing client request on the server.

Ähnliche Jobs
QA Manager (m/f/d)
Sandoz GmbH Vor 13 Tagen veröffentlicht
QA Manager (m/f/d)
Sandoz GmbH Vor 13 Tagen veröffentlicht
Mehr von ICON plc
Senior Clinical Trial Manager
ICON plc Vor 9 Tagen veröffentlicht
Project Manager
ICON plc Vor 9 Tagen veröffentlicht
Data Management, Project Manager
ICON plc Vor 8 Tagen veröffentlicht
Back to search page
;