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
Program Manager
Westmeath
R&D Engineer
Galway
Snr Process Engineer
Dublin North
Qualified Person
Dublin West
QA Manager
Meath
QA Manager Biologics
Dublin West
Microbiologist
Kilkenny
Principal Scientist
Dublin South
Senior Chemist
Dublin North
Snr QA Specialist
Dublin South
QA Manager
Dublin West
QA Specialist
Dublin West
Market Access Manager
Dublin City Centre
Head of Quality
Dublin West
CEO Medical Device Start Up
Republic of Ireland
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 applications@lifescience.ie
Details

QA Officer Biologics


Reference:ARPY-553022 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Analyst, QA Specialist

QA Officer Biologics
Our client, a global healthcare organisation, requires a QA Officer to join their team on a permanent basis. This is an excellent opportunity to work within the growing biologics space in Ireland.

Responsibilities
• Actively support the development and implementation of the Quality Management System
• Develop and maintain local Quality Systems, including standard operating procedures, change control, investigations, corrective and preventative actions, internal auditing, vendor qualification & management, GxP documentation management, batch disposition, complaints and annual product review for commercial and/or clinical operations as appropriate
• Author and review SOPs and Technical Agreements in accordance with procedure, and review Third party GxP documentation in support of Quality Systems and batch disposition
• Support operation of the Training system, including preparing and presenting relevant training material, as required, and manage the GMP Training program and deliver GMP Induction & Refresher training
• Ensure compliance with appropriate regulatory guidance documents, while driving improvements in product and process quality
• Maintain the Manufacturing License and revise when required, and manage Third Party key performance indicators
• Support the implementation of the Operational Excellence program through improvement initiatives
• Comply with company and Legislative Environment, Health and Safety Requirements
• Provide QA oversight of contracted Clinical Research Organisations including, Product Specification File generation and maintenance, review of clinical label packs, and support and execute any other duties as assigned.

Requirements
• 3rd level qualification in science related discipline
• Minimum 3 years’ experience within a Pharmaceutical QA role
• Relevant experience in GMP/GCP environment - Biologics, Sterile, Clinical and/or Combination Products an advantage
• Background in Regulatory Affairs an advantage
• Strong organisational skills / ability to prioritize work
• Proven track record as a team player
• High level of proficiency in Microsoft Word/Excel


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252