attention to detail in terms of task execution and QA review and
proven in Risk Based Decision Making – ability to assess both the
impact of an event that occurs and the suggested path-forward, in the
pharmaceutical or biotechnology industry?
This is a contract role based in Dun Laoghaire, Dublin.
BIOTECH PLANT QUALITY ASSURANCE ANALYST - 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 Plant Quality Assurance (QA) Senior Associate will report to a
Senior QA Manager and is a core member of the site QA team.
The QA Snr Associate will act as Quality point of contact for
manufacturing operations and is responsible for oversight of Medical
Device assembly and Serialized Packaging and labelling
Perform all activities in compliance with 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 pack check and deft assessment
Perform Batch Review to support customer complaint investigations
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 policies.
Support continuous improvement and operational excellence initiatives
Any other tasks/projects assigned as per manager’s request.
Purposeful Presence on the floor:
Triage
PPOF
Defect Classification
Pack Checks
Audit Walks
QA Lock outs
Quality Review:
Logbooks
GMP Documentation
Batch Records
Deviations
Protocols
REQUIREMENTS
Hold a third level qualification in a science related discipline
Strong attention to detail in terms of task execution and QA review.
Proven in Risk Based Decision Making – ability to assess both the
impact of an event that occurs and the suggested path-forward.
Excellent written and verbal communication skills – ability to
communicate across different teams/backgrounds & up/down different
levels with the organisation.
Strong organizational skills, including ability to follow assignments
through to completion – ability to work well on own and as part of a
dynamic team.
Knowledge of applicable Regulatory requirements, and ability to
evaluate compliance issues
Operational Excellence / Continuous improvement experience – ability
to identify areas for improvement & implement said improvements.
Problem solver
Advising and finding a complaint path forward
Previous Production experience
Ability to do shift role */5 (at the moment
shift schedule can change according to business needs, notice will of
course be provided of ant change to cycle)
PACKAGE
Contract role - Hourly rate € * - €**Apply
on the website** per hour
Shift: uplift = *%
Minimum * month contract
Onsite Expectations: 5 days per week Shift role **Apply on the
website**/5 role
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 36 Per Hour
Category: Construction
