pharmaceutical or biotechnology industry including working in aseptic
operations, protein formulation, vial and syringe filling?
This is a contract role based in Dun Laoghaire, Dublin
If interested, please forward your CV to * for
review or call *- * to
discuss in confidence.
QA ANALYST - BIOTECH INCOMING INSPECTION - 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.
Contractors have a history of either extending their contract or being
offered permanent positions on this site.
You will be an active member of the QA team and will be assigned to
the IQA Quality functional area, which is responsible for the
inspection and release of primary packaging components.
You will report to a QA Senior Manager and will serve as Quality point
of contact for Incoming Inspection of Primary and packaging
components.
The site is focused on continuous improvement of all work processes
and practices, therefore in addition to routine Quality Assurance
duties, you may be asked to carry out additional work functions to
support site continuous improvement activities.
Testing of primary and secondary components for use in the manufacture
of aseptic products.
Sampling of Excipients and Drug Substance under Grade C conditions.
Review/approve documentation associated with component testing in
preparation for QA Specialist or Qualified Person disposition
activities
Compiling, Review and approval of minor NC and CAPAs for closure
ensuring compliance with appropriate documentation, whilst ensuring
that CAPA actions address root cause and implementation plan dates are
achievable
Provide training and advice to staff in relation to testing of
components and packaging.
Actively participate in audits and their preparation.
Review cGMP records (e.g., WO, JP, GDMS, NC, CAPA, protocols, reports,
SOP, etc.) ensuring compliance with appropriate documentation
Write, review and approve Standard Operating Procedures in accordance
with site Policies.
Perform all activities in compliance with safety standards and SOPs
Support continuous improvement and Operational Excellence initiatives
Any other tasks/projects assigned as per manager’s request.
REQUIREMENTS
Must Pass Eye-Tests required for Visual Inspection
University degree. Engineering or Science related discipline
preferred.
Relevant experience (4 yrs. +) working in the pharmaceutical or
biotechnology industry or other combination of experience and
educational background that may otherwise satisfy the requirements of
the role.
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 / Non-Conformance /Deviation investigations
Experience working in aseptic operations, protein formulation, vial
and syringe filling.
PACKAGE
Contract role. € *- €**Apply on the
website** Per Hour
Min * month contract
Expectations are to be onsite FIVE days a week and it’ll also be a
shift role.
We will have people coming in from *:**Apply on
the website** to *: *,
Monday to Thursday, *: *
to *: * on a Friday.
Late shift is from *: *
to *: * Monday to
Thursday, *: * to **Apply
on the website**: * on a Friday.
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 35 Per Hour
Category: Construction
