or biotechnology industry ?
Must Pass Eye-Tests required for Visual Inspection
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.
QUALITY ASSURANCE SPECIALIST - 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.
You will be an active member of the ADL QA team and will be assigned
to the IQA Quality functional area, which is responsible for the
inspection and release of primary packaging components.
Will report to a QA Senior Manager and will serve as Quality point of
contact for Incoming Inspection of Primary and packaging components.
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 Amgen Policies.
Perform all activities in compliance with Amgen safety standards and
SOPs
Support continuous improvement and Operational Excellence initiatives
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 - Hourly rate € * - €**Apply
on the website** per hour
Minimum * month contract
Shift Cycle (8 hr days and evening rotation)= *
% rate uplift
We need : English (Good)
Type: Permanent
Payment: EUR 30 - 35 Per Hour
Category: Construction
