Senior Associate Quality Control NPI
Reference: RK2498
Duration: 12 Months
Location: 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:
* 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.
Education and 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 interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or rachel.kent@lifescience.ie for further information.
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