QA Specialist Senior, Contract Manufacturing 28791A
⦁ JobTitle: QA Specialist Senior, Contract Manufacturing 28791A
⦁ About Company: Our client based in Dun Laoghaire is seeking a Quality Assurance Specialist Senior to join its expanding team
⦁ Duration of Role: 12 months
⦁ Summary Objective: The Specialist QA is a position within the Quality Regional Work Cell in Europe reporting to the Senior Manager, QA (ESQ). The QA Specialist will be required to understand and grasp a wide range of quality related competencies while providing high complexity tactical support to Site Leads across multiple Quality Systems and Processes.
⦁ Job Duties:
• 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 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
candidate may have to travel to the US for some training, but the manager doesn’t envisage that this is will be a regular occurrence, but candidate still needs to be open to travel to the US if required
SKILLS AND REQUIREMENTS (no visa processing)
• Doctorate degree OR
• Master’s degree & 2 years of directly related experience OR
• Bachelor’s degree & 4 years of directly related experience OR
• Associate’s degree & 10 years of directly related experience OR
• High school diploma / GED & 12 years of directly related experience
• 4+ years of quality and manufacturing experience in biotech or pharmaceutical industry
• Bachelor’s Degree in a Science Field
• cGMP Experience knowledge of FDA and EMA regulations.
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
external contract manufacturers,
implementing process improvements.
Previous experience with trackwise, LIMS, and/or SAP
Benefits of working with Independent Solutions
> Excellent Team of Colleagues
> Access to high-value projects
> Excellent Technical Project Managers
> Excellent pay & conditions
Independent Solutions are Approved Suppliers for Multinational Pharma Biotech, Medical Device, clients with locations based here in Ireland.
At Independent Solutions, we will not require you to become an employee of Independent Solutions, we will facilitate and support you to become an independent contractor, thereby reaping the maximum rewards from your contract role.
We work in the area, we know the business, we are not a recruitment agency!
We continue to partner and grow our client base and thereby ensure that we have continuous supply of excellent roles
Yes, of course we benefit from having YOU with US, but we can assure YOU that YOU too will benefit …
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