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Contact Info
Jack Caffrey
Life Science

01 507 9279
[email protected]
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Details

Senior Quality Assurance Specialist


Reference:JSC00030442 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QA Specialist

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.

Duties

•Provide high complexity tactical support to Site Leads across multiple Quality Systems and Processes.
• 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
• Collaborate with Complaints team to request assessments, reviews complaint report and have comments addressed
• Provide tactical information to the networks (i.e., metrics to QMR, MR, data analysis, trending, periodic monitoring, APR)
• Escalate risks or roadblocks to management
• Drive timely decision making using DAI principles
• Drive continuous improvements and Amgen first mindset
• Train on required Quality Systems (NCMS, CCMS, LIMS, SAP, Complaints, and others as applicable)
• 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

Education & Experience

• 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
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Familiarity with basic project management tools
• 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 sites
• Min Bachelor’s degree & 4 years of directly related experience
• cGMP Experience
• Ability to oversee multiple projects simultaneously
• Able to successfully manage workload to timelines
• Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
• Main areas of responsibilities will be
•Manage and own NC records for External Quality
•Manage and own CAPA records for External Quality
•Manage and drive Quality records to closure independently

Candidates MUST have previous experience in these areas to be able to work independently
Trackwise is the system used onsite.