QC Associate NPI (Senior)

Global Biotechnology company, based in south Dublin, Ireland – looking for QC Associate (Senior).

The successful candidate will be responsible for QC analytical testing, characterization, sample and data management. This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

The Job:

* QC Representative for NPI activities and routine Product meetings.
* Assist with activities related to QC projects and/or QC tasks within Site projects
* Plan and perform non-core testing related to NPI activities.
* Manage all sample management activities related to NPI activities throughout the site.
* Create/own and approve protocols, sample plans, SOP and documentation related to NPI.
* QC Representative responsible for Method Validation and Transfers co-ordination and readiness.
* Responsible for their own training and safety compliance.
* Sample shipments and temperature monitoring activities for NPI activities.
* LIMS data coordination of non-core (NPI) activities.

Have You:

* Bachelor’s degree in a science discipline.
* 3+ years of bio pharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
* Strong background in Chemistry and Analytical testing is required.
* 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.

The successful candidate must have eligible working VISA in Ireland or European Union (EU) passport.

Berkley Life Science & Engineering is a specialist consultancy, recruiting professionals for organizations throughout Ireland, UK & Europe; for more information go to www.berkley-group.com

If you would like to discuss this vacancy further or to discuss your career options in confidence, please telephone Aleksas Kremenskas at +353 (0) 87 2727949 or send your profile to akremenskas@berkley-group.com