QC Senior Associate (NPI Snr Associate)

Team Horizon is seeking a Sr Associate QC (Senior) for our client based in Dublin. In this role under minimal supervision, you will be responsible for one or more of the following activities in QC including analytical testing, characterization, sample and data management.
 
 
Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.


• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.


• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.

 
What you will be doing:

• 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.


• May represent the department/organization on various teams. May train others.


• May interact with outside resources

 
What you need to apply:

• • Bachelor’s degree in a science discipline. 2-3 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 regulatory compliance in cGMP manufacturing and testing of pharmaceutical products. 


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


• Deepens technical knowledge through exposure and continuous learning.