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Senior QC Specialist
- BBBH767043 Sep 24, 2020 €50 - €60 ph
Under minimal direction, this role functions as the specialist for the NPI project team.
This role will be involved in NPI project and/or Method Transfer projects on an ongoing basis.
These projects can relate to all areas of QC including analytical testing, characterization, sample, data management, equipment qualification and Project management.
- QC Representative for site upgrade projects / laboratory /NPI activities and routine Product meetings
- Plan and manage QC related activities from site projects.
- Plan and Perform non-core testing related to NPI activities
- Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
- Report, evaluate, back-up/archive, trend and approve analytical data.
- 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
- 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.
- Contributes to team by ensuring the quality of the tasks/services provided by self
- Contributes to the completion of milestones associated with specific projects or activities within team
- May contribute to regulatory filings.
- May conduct lab investigations as necessary.
- Evaluate lab practices for compliance on a continuous basis.
- Approve lab results
- Create APPX data files and randomisation memo to facilitate data analysis.
- LIMS data coordination of commercial and import testing on site where applicable
- At least 5 years in a cGMP regulated environment
- NPI and Method Transfer experience is a must
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
+353 21 2300300