Job Details: Quality Assurance Specialist


jobContax

104 Upper Drumcondra Road,
Dublin 9
http://www.jobcontax.com
Please contact: Karen
JobContax was founded in 2001 by Karen McHugh, an engineer passionate about offering quality opportunities to the jobseeker and an intelligent service to the client. Jobcontax has successfully operated as a global market leader and technical specialist within the following sectors:

Construction and Infrastructure

Engineering and Design

Mining - Oil and Gas

Biotechnology and Pharmaceutical

During the past 10 years Jobcontax have expanded our international network across 5 continents. In 2005 we began recruiting for the Australian market and in 2011 we set up our first strategic partnership in WA. In March 2010, we opened our Shanghai office to strengthen our presence in the rapidly expanding Chinese market for highly skilled professionals. JobContax has a strong presence in Canada, Europe and the Middle East.

Jobcontax has built its reputation on its consultative approach. Our understanding of the industries and the businesses and individuals within these industries enables us to facilitate the perfect match between client and jobseeker. From global multinationals to SME?, Jobcontax has become the trusted recruitment partner.
Quality Assurance Specialist


Are you a Quality Assurance Specialist with experience in a biologics / pharmaceutical / medical device setting? Have you experience in material/supplier investigations supporting raw material quality issues?  Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Senior Quality Assurance Specialist - Amgen - Dublin



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description


The successful candidate will report to the Senior Manager QA and provide Quality oversight of Warehouse operations, including disposition of raw materials, project support and change control management

Key Responsibilities:

Perform material/supplier investigations supporting raw material quality issues

Perform change control management of supplier initiated changes

May own specifications, non conformance & CAPA records and change records

Manage Raw Material reserve samples

Negotiate quality agreements with suppliers

Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.).

May own site quality system(s) and standard operating procedures

May represent ACO on global network teams and support of new initiatives

Metrics compilation and reporting

Provide SAP expertise 

 
Requirements: 

Basic Qualifications

University degree gained in Chemistry, Biology or Science related discipline.

Significant experience gained within the pharmaceutical or biotechnology industry.



Preferred Qualifications

Excellent written and verbal communication skills

Experience working with raw material suppliers

Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP

Knowledge of applicable Regulatory requirements

Experience with Regulatory inspections desirable

Operational Excellence experience desirable

Experience leading cross-functional teams desirable

Experience utilizing Lean principles and a risk-based approach desirable

Experience working with teams and influencing decisions



Package:

Basic rate of €35 - 40 per hour

Minimum Contract duration: 12 months



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Amgen Jobs in Ireland

Are you a Quality Assurance Specialist with experience in a biologics / pharmaceutical / medical device setting? Have you experience in material/supplier investigations supporting raw material quality issues?  Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? If you have what it takes, send your CV to karen@jobcontax.com or call (01)7978720 for a confidential chat.



Senior Quality Assurance Specialist - Amgen - Dublin



Employer

Our Client is Amgen and the role will be based in their Dun Laoghaire plant. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment.



Job Description


The successful candidate will report to the Senior Manager QA and provide Quality oversight of Warehouse operations, including disposition of raw materials, project support and change control management

Key Responsibilities:

Perform material/supplier investigations supporting raw material quality issues

Perform change control management of supplier initiated changes

May own specifications, non conformance & CAPA records and change records

Manage Raw Material reserve samples

Negotiate quality agreements with suppliers

Collaborate with Global SQM to provide supplier performance feedback (e.g. supplier scorecards, supplier audits, etc.).

May own site quality system(s) and standard operating procedures

May represent ACO on global network teams and support of new initiatives

Metrics compilation and reporting

Provide SAP expertise 

 
Requirements: 

Basic Qualifications

University degree gained in Chemistry, Biology or Science related discipline.

Significant experience gained within the pharmaceutical or biotechnology industry.



Preferred Qualifications

Excellent written and verbal communication skills

Experience working with raw material suppliers

Understanding/experience with Trackwise, Change Control Management System, EDMQ and SAP

Knowledge of applicable Regulatory requirements

Experience with Regulatory inspections desirable

Operational Excellence experience desirable

Experience leading cross-functional teams desirable

Experience utilizing Lean principles and a risk-based approach desirable

Experience working with teams and influencing decisions



Package:

Basic rate of €35 - 40 per hour

Minimum Contract duration: 12 months



Contact:

Karen McHugh is the consultant managing this position. If you have any queries about this role, you can contact Karen by e-mail karen@jobcontax.com or phone +353-1-7978720

Click to connect with Karen on LinkedIn



Similar Jobs

Amgen Jobs in Ireland

We need : English (Good)

Type: Permanent
Payment: package
Category: Pharmaceutical

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