I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Sinead Cullen
Life Science

01 507 9252
[email protected]
Connect with me on
Validation Lead
Limerick
eClinical Project Manager
Republic of Ireland
Technical Writer
Limerick
Project Manager
Limerick
QA Manager
Dublin
Process Engineer
Dublin North
Process Engineer
Limerick
R&D Engineer
Limerick City
Qualified Person
Waterford
Senior R&D Engineer
Limerick City
Business Program Lead - Remote
Republic of Ireland
R&D Manager
Galway
Head of R&D
Galway
eClinical Project Coordinator
Republic of Ireland
QC Scientist
Limerick
Project Engineer
Limerick
Clinical Research Associate (CRA)
Republic of Ireland
R&D Manager
Limerick
Project Engineer
Limerick
Quality Engineer
Limerick
C&Q Engineer
Dublin
Senior Planner
Limerick
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Site Lead Auditor


Reference:SCASFB-553526 Location: Meath
Qualification:DegreeExperience:10+ Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Quality Auditor

Site Lead Auditor
Our client, a global healthcare organisation are currently recruiting for a Site Lead Auditor to join their team on a permanent basis. As Site Lead Auditor you will be responsible for leading the implementation of the Site Internal Audit Program and Supporting the launch of the Inspection Readiness Program ensuring the processes comply with GMPs, Health Agency regulations and all other applicable governing regulations on site.

Responsibilities

  • Comply with company and regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions
  • Ensure there is an effective Quality Management System in place
  • Lead proactive evaluation of site compliance against emerging regulatory trends
  • Support deviation and atypical close out and initiate/follow up on Corrective and Preventive Action
  • Initiate and maintain Quality related metrics related to the Site Internal Audit program, ensuring effective communication and follow up
  • Represent the sites Quality Management System during Board of Health inspections
  • Manage the internal audit schedule
  • Effectively communicate audit/inspection results to stakeholders. Evaluate root cause analysis, Corrective and Preventive Actions (including responses, completion, and effectiveness) for audits & inspections
  • Lead the preparation and host Health Authority inspections and Divisional Audits
Requirements
  • BSc/BEng Chemistry/Biology/Microbiology/ Automation/Engineering or a relevant discipline
  • Seasoned Site Inspection & Audit professional with a circa 12 years’ working knowledge in the Pharmaceutical or Biological industry
  • Minimum of 4 years’ direct involvement in delivering Site Internal Audit programs and Inspection Readiness programs in a regulated environment
  • In-depth knowledge of US and European cGMP guidelines and ICH guidelines