Quality Assurance Specialist - Dun Laoghaire - Dublin


Location: Ireland

EUR 45 - 50 Per Hour

Job Type: Contract

Industry: Biotech-Pharma-Medical-Device-Jobs

Job ID: JO-1908-19236

Consultant: Karen McHugh






Do you have 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry?

Would you like to work for Amgen, a company who provides an outstanding work environment and opportunities for career development? 

If you have the relevant experience, please forward your CV to karen@jobcontax.com for review or call 353 1 7978720 to discuss in confidence.

 

Quality Assurance Specialist - Dun Laoghaire - 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

Manage and own NC records for External Quality 

Manage and own CAPA records for External Quality 

Manage and own Change Control records internal to External Quality 

Manage and drive Quality records to closure independently 

Perform tactical batch disposition activities in support of lot release 

Provide tactical information to the networks (i.e., metrics to management, data analysis, trending, periodic monitoring, APR) 

Escalate risks or roadblocks to management 

Drive timely decision making using Amgen decision making principles 

Drive continuous improvements and Amgen first mindset 

Demonstrate ownership for required training on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable) 

Engage &/or participate with ongoing improvement initiatives within the Regional work cell and the wider organisation 

Align and support the tools in use to manage Regional Work Cell activities including Visual management, level loading, capacity & capability management 

Create and foster an environment of change and development within the Regional Work Cell and seek to influence beyond. 

Create and foster key relationships to enable timely completion of activities and responsibilities. 

Own Quality record content 

Works under minimal direction 

Identify opportunities and issues, then determine when escalation is necessary 

Proposes revisions to SOPs in area of responsibility 

Identifies key improvement opportunities and highlights to management 


Requirements 

4+ years of quality and manufacturing experience in biotech or pharmaceutical industry 

Bachelor’s Degree in a Science Field 

cGMP Experience 

Ability to oversee multiple projects simultaneously 

Able to successfully manage workload to timelines 

Ability to negotiate a position after taking feedback from multiple sources 

Demonstrated ability to consistently deliver on-time, and high-quality results 

Ability to operate in a matrixed or team environment 

Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes) 

Ability to travel +/- 10% of time to domestic and international Amgen sites


Package

Excellent Hourly Rate

Minimum 12 month contract

 

Contact

Karen McHugh is the consultant managing this position.

If you have any queries about this role, you can contact him by e-mail karen@jobcontax.com or phone +353-1-7978720

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