We are actively seeking to recruit a Senior QC Specialist to become a key member of the quality team within a Dublin based biopharmaceutical manufacturer.
The successful candidate must be experienced within both NPI and Method Transfer
and will be responsible for one or more of the following activities in QC including analytical testing, characterization, sample, data management, equipment qualification and Project management.
• QC Representative for site / laboratory upgrade projects
• Plan and manage QC related activities from site projects.
• QC Representative for NPI activities and routine Product meetings
• Plan and Perform non-core testing related to NPI activities
• Manage all sample management activities related to NPI activities throughout the site Sample shipments and temperature monitoring activities for NPI activities
• Create/own and approve protocols, sample plans, SOP and documentation related to NPI
• Responsible for their own training and safety compliance.
• Assist with resource management, QC Project Management and other work streams as required by the lab management.
• Authoring, executing and documenting the qualification of existing laboratory equipment in a cGMP regulated environment. Writing equipment validation protocols and associated summary reports.
Basic Qualifications & Experience:
-A minimum of 5 years previous experience in a cGMP regulated environment
-NPI and Method Transfer experience is a must
-Routine testing background with the technical know how, moved into project NPI/Method transfer roles
-Ability to develop a plan identifying individual strategies, validation/qualification etc
-Looking for a team player, able to work in a fast paced environment, influencing skills and contribute to a positive team dynamic