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Senior QA Specialist

Reference:JSC00029956
Location: Dublin
Qualification:Degree
Experience:3-4 Years
Job Type:Fixed Term Contract
Salary:Not Disclosed
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May be suitable for: EHS Specialist, 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)
Authority

• 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


•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



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