Senior Associate Quality Control NPI

4 weeks ago

Dublin, Ireland Life Science Recruitment Full time
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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