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Details

Senior QC Associate NPI


Reference:SMC028626 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

Summary

We’re currently recruiting for an exciting opportunity with an award winning Pharmaceutical organization based in Dublin. This is an excellent opening for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

• QC Representative for NPI activites 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 activites
• Manage all sample management activities related to NPI activites 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 activites
• LIMS data coordination of non-core ( NPI) activites.
• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform analyses with great efficiency and accuracy.
• 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.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents.
• May train others as necessary
• Participate in audits, initiatives and projects that may be departmental or organizational in scope.
• Write protocols and perform assay validation and equipment qualification/ verification.
• Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
• May contribute to regulatory filings.
• May conduct lab investigations as necessary.
• Evaluate lab practices for compliance on a continuous basis.
• Approve lab results
• May represent the department/organization on various teams
• May interact with outside resources.
• Create APPX data files and randomisation memo to facilitate data analysis.
• LIMS data coordination of commercial and import testing on site where applicable
• May provide technical guidance.May contribute to regulatory filings.

Education & Experience

• 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,
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.


If you would like further Information you can contact the recruiter directly:

Sean McCarthy | Tel: +353 (0) 87 798 8480