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December 13 2018

    Job details


Job description:

   » Job ID.:15406764
   » Employer ID.:RI/
   » Published:15-NOV-2018
   » income:COMPETITIVE
   » Job location:DUBLIN
   » Employment Type:CONTRACT


Job Title Quality Assurance Specialist senior

About Company Our client located in Dun Laoghaire is seeking aQuality Assurance Specialist to join its expanding team.

Duration of function 12 months

Summary Objective The QA Specialist will report to a QA Senior Manager and will be required to be a Subject Matter Expert in the Incoming Quality Assurance Area (IQA) area.

Job tasks
•Provide Subject Matter skills in relation to the testing of primary and packaging components for use in the manufacture of aseptic products.
•Plan and perform routine analyses with efficiency and accuracy.
•Approve IQA Incoming test results.
•Manage the introduction of new techniques to QA Incoming, including method transfers, and validations
•Write protocols and perform validation and equipment qualification/verification.
•Assume ownership and/or oversight of change control and NC/CAPA records; ensuring the scope of record is clear and implementation activities are robust and timely.
•Write, review and approve Standard Operating Procedures in conformity with Amgen Policies.
•Participate in customer complaint investigations with suppliers of components and packaging.
•Provide training and advice to staff in relation to testing of components.
•Actively participate in audits and their preparation.
•Evaluate practices for compliance and operational excellence improvement on a continuous basis.
•Perform all activities in compliance with Amgen safety standards and SOPs

Requirements Skills andpractice Novisa processing

A primary component is a vial, a syringe, or stopper in direct contact with the product.
A secondary packaging component is something like a printed leaflet or printed carton.
Basic Qualifications
•University degree. Engineering or Science related discipline preferred.
•significant practice (8yrs ) working in the pharmaceutical or biotechnology industry or other combination of practice and educational background that may otherwise satisfy the requirements of the function.



Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Dublin
Company Type Employer
Post Date: 11/15/2018 / Viewed 7 times
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