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
Jack Caffrey
Life Science

01 507 9279
[email protected]
Connect with me on
Process Engineer
Dublin North
R&D Engineer
Limerick City
Business Program Lead - Remote
Republic of Ireland
R&D Manager
Galway
Project Manager
Limerick
C&Q Engineer
Dublin
Validation Lead
Limerick
eClinical Project Coordinator
Republic of Ireland
Project Engineer
Limerick
Head of R&D
Galway
Clinical Research Associate (CRA)
Republic of Ireland
QA Manager
Dublin
Project Engineer
Limerick
Senior R&D Engineer
Limerick City
Qualified Person
Waterford
Process Engineer
Limerick
Quality Engineer
Limerick
Technical Writer
Limerick
QC Scientist
Limerick
Senior Planner
Limerick
eClinical Project Manager
Republic of Ireland
R&D Manager
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

Senior Quality Assurance Specialist


Reference:JSC00031055 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Analyst

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in South Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• Accountable for Quality oversight of processes and procedures related to IS, Computerised Systems & Automation compliance (ex: BMS, PCS, FMS, HMI upgrades etc..)
• Quality review and approval of CSV documentation
o Review of Risk Assessments, DS, URS & QRAES documents
o Review of validation Plans, Protocols, IQ, OQ, PQ and associated validation documents
o Review of executed validation documents and reports
• Perform all activities in compliance with Amgen safety standards and SOPs
• Be involved in all Validation Cross Functional Teams (CFTs) at the site to ensure adherence to required policies and procedures.
• Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations.
• Provide Quality direction and input at Change Control and Deviation Review Boards and assume QA oversight of change control and Deviation/CAPA records; ensuring scope of record is clear and implementation activities are robust and timely.
In line with business requirements, these responsibilities may expand or otherwise include additional areas of responsibility which are not described in this specification but are associated with the role

Education & Experience

• University degree. Science or Engineering related discipline preferred.
• Relevant experience (7 yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing quality direction of introduction of significant project such as new MES or BMS system.
• Ability to work independently and remotely with minimum direct supervision.
• Critical thinking skills.
• Strong organisational, communication, coordination, and meeting facilitation skills.
• Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration.
• Team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.