Senior Associate Quality Control NPI
RK3640
12 Months
Dublin

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position 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 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.

• 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.



Education and Experience :

• Bachelor’s degree in a Science related field is required.
• 3 years of biopharmaceutical 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 HPLC, Troubleshooting and Empower is required