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
Production Team Lead
Dublin South
Quality Specialist
Tipperary
Project Engineer
Limerick
Senior CSV Specialist- Hybrid
Republic of Ireland
Process Engineer
Limerick
Controls Engineer
Dublin South
NPD Manager
Galway
GCP Inspector
Dublin
Clinical Evaluator
Republic of Ireland
Quality Engineer
Limerick
Project Engineer
Limerick
Senior R&D Clinical Engineer
Republic of Ireland
R&D Manager
Galway
Product Planner
Longford
Project Engineer
Limerick
Controls Engineer
Dublin South
QA Contractor
Dublin City Centre
NPD Manager
Galway
Quality Engineer
Limerick
Design Assurance Engineer
Republic of Ireland
C&Q Engineer
Dublin
Engineering Technician
Dublin South
Engineering Technician
Dublin South
R&D Engineer
Dublin
Process Engineer
Republic of Ireland
R&D Engineer
Galway
Senior R&D Engineer
Limerick City
R&D Manager
Galway
Project Engineer
Limerick
QC Leader
Cork
EH&S Specialist
Longford
NPD Manager
Galway
Process Lead
Donegal
Project Manager
Limerick
Regulatory Affairs Specialist
Republic of Ireland
Controls Engineer
Dublin South
Head of R&D
Galway
Global Head of R&D
Republic of Ireland
R&D Engineer
Limerick City
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:JSC00032315 Location: Dublin
Qualification:DegreeExperience:7-9 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Executive

We’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in 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.

Description:

The Quality Assurance Technical Support (QA TS) Specialist is a senior position within the QA function which will typically report to a QA Manager and will be required to be a Subject Matter Expert in their assigned area of responsibility.

• Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations.
• Quality review and approval of Technology Transfer, Qualification/Validation documentation and SOPs to support site activities:
o DS, URS & QRAES documents
o Validation Plans, Protocols, IQ, OQ, PQ and associated documents
o Executed validation documents and reports
• Act as Quality point of contact and decision maker during New Product Introductions, Technology Transfer and Qualification/ Validation activities whilst ensuring that all activities meet Amgen and regulatory expectations.
• 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.
• Quality review/approval of BOMs, MBRs and recipes.
• Write, review and approve Standard Operating Procedures in accordance with Amgen Policies.
• Perform all activities in compliance with Amgen safety standards and SOPs
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

Preferred Qualifications

• University degree. Science or Engineering related discipline preferred.
• Relevant experience (7yrs +) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert providing overall quality direction and oversight for NPI/ technology transfer / product lifecycle changes.
• Understanding of principles of Validation and New Product Introduction
• Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
• Ability to operate across functional boundaries, both internal and external.
• 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.