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
Alan O'Riordan
Life Science

+353873657522
[email protected]
Connect with me on
Project Engineer
Republic of Ireland
Project Engineer
Tipperary
CSV/CQV Lead
Louth
Head of R&D
Galway
CQV Lead
Tipperary
Responsible Person (RP)
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
Project Manager
Limerick
Project Manager
Limerick
Chemical Engineer
Tipperary
Project Engineer
Limerick
Senior R&D Engineer
Galway City
R&D Manager
Galway
Medical Device Director
Republic of Ireland
Quality Specialist
Tipperary
C&Q Lead
Tipperary
R&D Engineer
Dublin
Senior Manufacting Engineer
Republic of Ireland
Senior Recruitment Consultant
Republic of Ireland
R&D Director
Galway
R&D Manager
Galway
R&D Manager
Galway
R&D Director
Galway
QC Analyst
Cavan
Process Engineer
Limerick
Recruitment Consultant
Republic of Ireland
R&D Manager
Galway
Project Engineer
Limerick
R&D Director
Galway
Trainer
Dublin
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

Qualified Person - Pharmaceutical


Reference:AOORASYW-885602 Location: Cork
Cork City
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

QA Specialist/QP

Description
My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business of the company, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. At their campus at Cork, they employ approximately 600 staff and are a 24/7 operation exporting to 93 markets worldwide.

As QA Specialist/QP, you will manage and drive the site QA systems in close cooperation with other specialists in the QA Product Quality Team. You will coordinate and execute all QA duties relating to QP batch release and communicate all issues.

Responsibilities
• Coordination of the certification of finished product batches to the market as required under the EU directive 2001/83/EC
• Ensure that the batch and its manufacture comply with GDP, GMP, Regulatory Licences and Marketing Authorization
• Maintain oversight of deviations, CAPA & Change Controls and ensure any issues which have a regulatory impact are notified to health authorities and mitigated as required
• Continuous improvement of the manufacturing and quality systems – Identifying and building in efficiencies as necessary from a systematic and compliance perspective
• Coordinate support for operations in general troubleshooting and problem solving, providing technical direction and guidance to support overall business needs
• Maintain up-to-date knowledge of pharmaceutical legislation and industry best practice.
Qualifications and experience
• 3rd level qualification in Science / Engineering discipline or equivalent knowledge or experience
• Significant experience within a GMP / QA environment in a pharmaceutical company or similar regulated environment
• Eligible to act as a Qualified Person in line with local and EU directives.

Desired Skills
• Ability to create and maintain effective interpersonal relationships with all levels of personnel within all cross functional departments in the organization
• Excellent communication, negotiation and risk based decision making skills, promoting openness, dialogue and collaboration
• Results oriented with a strong ability to effectively troubleshoot and problem solve issues
• Promote a continuous improvement culture.

Eligibility requirements

  • A good level of English and a valid work permit
  • Level 8 degree that enables you to be QP eligible (MSc Pharm for example)


If you are interested in this role, contact Alan on [email protected] / 087 365 7522