Quality Control NPI Senior Associate – REF 01989NOS

We are actively seeking to recruit a QC Specialist to become a key member of the quality team within a Dublin based biopharmaceutical manufacturer.

The successful candidate will join the NPI team and will be responsible for one or more of the following activities in QC including analytical testing, characterization, sample, data management

Primary Responsibilities:
• 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
• 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.

Qualifications & Experience:

·       BSc in Science or Engineering

·       3+ Years experience within the pharmaceutical industry

·       Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories.

·       Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery

·       Applies analytical skills to evaluate and interpret complex situations/ problems using multiple sources of information

·       Strong Technical Writing skills for GMP documentation

·       Works under minimal direction

·       Take initiative to identify and drive improvements

·       Communication skills (verbal and written) at all levels

 

For more information and a full job spec contact Nicola on 087 0622429 or email your CV in the strictest confidence to [email protected]

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