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Details

Senior Associate Quality Control NPI


Reference:RK2498 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Fixed Term ContractSalary: Not Disclosed
May be suitable for: QC Analyst

Senior Associate Quality Control NPI
RK2498
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:

  • 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



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.