experience.
Do you have knowledge and experience in managing Root Cause Analysis /
Deviation investigations
If you have the relevant experience, please forward your CV to **Apply
on the website** for review or call * **Apply
on the website** to discuss in confidence.
QA SPECIALIST - BIOTECH PQA - DUBLIN
JOB DESCRIPTION
Our client is a leading international Biotechnology company with a
state of the art aseptic manufacturing facility in Dun Laoighaire,
South Dublin.
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
plant.
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.
Key Responsibilities:
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
deviation
events.
Review/approve deviations for closure ensuring compliance with
appropriate
standards.
Review/approve production batch records, and associated documentation
in
preparation for qualified person disposition activities.
Provides training and advice to staff in order for them to perform
their desired
functions.
Write, review and approve standard operating procedures in accordance
with
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
preferred.
Relevant experience (4 years +) working in the pharmaceutical or
biotechnology industry or other combination of experience and
educational
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
Root
Cause Analysis / Deviation investigations
Internal Use Only General and Administrative
Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
Operational Excellence experience
PACKAGE
Competitive salary depending on experience
We need : English (Good)
Type: Permanent
Payment: Negotiable
Category: Construction
