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QA SPECIALIST - BIOTECH PQA - DUBLIN
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
The plant is one of the most dynamic in Ireland and is currently
undergoing rapid expansion and capital investment.
This is an excellent opportunity to get experience into
Ireland *;s leading aseptic manufacturing
The Quality Assurance (QA) Senior Associate will report to a QA
Manager and is a core member of the site Quality Assurance team.
Quality point of contact for Plant Quality Assurance (PQA).
The site is focused oncontinuous improvement of all work processes and
practices, therefore in addition to
routine Quality Assurance duties, QA Snr Associates may be asked to
carry out additional work functions to support site continuous
improvement activities. This is a */7 shift
role required to support manufacturing operations.
The Plant QA team structure is one group responsible for oversight of
aseptic manufacturing (Formulation and Fill) and for oversight of the
Inspection and Packaging operation.
Perform all activities in compliance with Amgen safety standards and
standard operating procedures.
Observe and provide real-time quality oversight and support for
manufacturing on the floor.
Perform purposeful presence on the floor audits.
Perform manual visual inspection AQL audits of vials and syringes.
Perform QA reserve sample inspections as part of the annual reserve
inspection program and in support of customer complaint investigations
Certification of defect panels.
Provide quality support for triage and investigation of all classes of
Review/approve deviations for closure ensuring compliance with
Review/approve production batch records, and associated documentation
preparation for qualified person disposition activities.
Provides training and advice to staff in order for them to perform
Write, review and approve standard operating procedures in accordance
our clients policies.
Support continuous improvement and operational excellence initiatives
Any other tasks/projects assigned as per manager’s request.
Basic Qualifications & Experience:
University degree. Engineering or Science related discipline
Relevant experience (4 years +) working in the pharmaceutical or
biotechnology industry or other combination of experience and
background that may otherwise satisfy the requirements of the role.
Preferred Qualifications & Experience:
Excellent written and verbal communication skills
Experience working with dynamic cross-functional teams and proven
abilities in decision making
Strong organizational skills, including ability to follow assignments
through to completion
Demonstrated ability in problem solving and experience in managing
Cause Analysis / Deviation investigations
Internal Use Only General and Administrative
Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
Operational Excellence experience
Competitive salary depending on experience
We need : English (Good)