QC Senior Associate


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2022-04-26 09:26:281970-01-01Team Horizon
Job TypeContractor
AreaDublinDublinIreland
SectorLaboratory/Scientific
Start Date
AdvertiserMary King
Job Ref2449
Job Views244
Description
We are seeking applications for an experienced QC Senior Associate (QC Sample Management)
for our client, who is a leading biopharmaceutical company based in Dublin. Under minimal supervision, you will be responsible the following activities in QC including sample and data management and equipment maintenance. Contributing to team by ensuring the quality of the tasks/services provided by self.  You will also contribute to the completion of milestones associated with specific projects or activities within team.
 
Why you should apply:
·        This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
·        There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
·        Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
 
What you will be doing:
·        Liaise with site Planning, Manufacturing and Inspection regarding ADL 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 ADL 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.

 
What you need to apply:
·        Bachelor’s degree in a Science related field is required.
·        5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry, where 2 – 3 years of specific sample management/ stability programme experience is desirable.
·        Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
·        Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
·        Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
·         
 
 
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