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Senior Associate Qc

1 week ago

County Dublin, Ireland Life Science Consultants (Lsc) Full time

LSC have a great contract opportunity for a QC Senior Associate to join a South Dublin based Biopharmaceutical company that specializes in secondary manufacturing activities such as Formulation, Fill Finish and Packaging.
If you have 5 years of experience years in construction management/engineering within in the pharmaceutical or biotechnology industry and are ready for your next challenge, this could be the perfect project for you
KEY RESPONSIBILITIES: * 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.
Specific Job Duties: * 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.
ABOUT YOU - ARE YOUR SKILLS A MATCH?
* 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.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa.
Please note that we are unable to provide visa sponsorship.
Thank you for your understanding.
Apply via this advert or contact Grinne Hodnett on if you have any more questions about this opportunity
Skills: Quality Control LIMS SAP