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Senior Associate Quality Control NPI
4 weeks ago
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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