working in the pharmaceutical or biotechnology industry?
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.
QC SAMPLE MANAGEMENT - BIOTECH PLANT - 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.
Under minimal supervision, responsible for one or more of the
following activities in QC including sample and data management and
equipment maintenance.
Contributes to team by ensuring the quality of the tasks/services
provided by self
Contributes to the completion of milestones associated with specific
projects or activities within team
This role will support QC and manufacturing operations, as such some
extended hours and weekend work flexibility may be necessary as
required.
Liaise with site Planning, Manufacturing and Inspection regarding site
manufacturing schedule and required QC testing.
Liaise with Stability Product Representatives and Product Quality
Leads as required.
Perform routine sample management tasks as per procedures.
With a high degree of technical flexibility, work across diverse areas
within QC
Plan and perform multiple, complex routine/ non-routine tasks with
efficiency and accuracy.
Report, evaluate, back-up/archive, trend and approve data.
Troubleshoot, solve problems and communicate with stakeholders.
Initiate and/or implement changes in controlled documents and
equipment.
Participate in audits, initiatives, and projects that may be
departmental or organizational in scope.
Operate and maintain GMP equipment, including responding and
management of GMP alarms.
Introduce new techniques/ Processes to the area, where appropriate.
Evaluate sample management practices for compliance and operational
excellence improvement on a continuous basis.
LIMS data coordination of commercial and import testing lots where
applicable
LIMS lot logging for site manufactured lots.
Provide technical guidance, may contribute to regulatory filings.
Represent the department/organization on various teams as required.
Train others.
Interact with outside resources.
Perform general housekeeping in all sample management areas in line
with 5S.
Execute sample management activities across the site – sample
distribution, LIMS logging, shipment receipt
Perform Stability Program related activities such as pulling stability
samples, study initiations.
Create/own and approve protocols, sample plans., SOPs, training
manuals.
Perform SAP, LIMS and CIMS functions/ transactions within the sample
management remit • Out of hours responder for sample management
equipment (fridges /freezers / incubators)
Responsible for their own training and safety compliance.
Sample shipments and temperature monitoring activities.
LIMS data coordination of commercial and import batches.
Management and maintenance of the Site Inventory of Reference
Standards, Assay Controls, Training and Verification samples.
QC Representative for NPI activities and routine Product meetings as
required.
REQUIREMENTS
University degree. Engineering or Science related discipline.
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
Experience working in aseptic operations, protein formulation, vial
and syringe filling.
PACKAGE
Contract role. € *- €**Apply on the
website** Per Hour
Min * month contract
We need : English (Good)
Type: Permanent
Payment: EUR 25 - 33 Per Hour
Category: Construction
