• Cork

R.T. Lane Recruitment

Initial 12-month contract role.

Summary

We have an exciting opportunity for a QC Associate Scientist specializing in the Empower System. The successful candidate will be an essential part of the Empower team delivering Global Empower Master Projects. As the system SME they will ensure the system and supporting processes are always audit ready. They will lend their expertise during audits, investigations, RCPS and process improvements.

Your typical day may include

  • Resolve Empower Support tickets.
  • Build Global Empower Master Projects, Methods etc.
  • Perform System review activities.
  • Be a key Empower SME for all GmP audits.
  • Supporting quality investigations, CAPA’s & change controls, as required.
  • Consulting in lab-based investigations involving the use of problem solving and root cause analysis methodologies.
  • Providing training, mentoring and guidance as required.

Essential

  • A BSc level 8 degree in Chemistry/Biology/Biochemistry/Microbiology, or another Scientific related field.
  • 3+ years’ Empower SME experience (administrator or key user experience, i.e., creating methods, data acquisition, processing & review).
  • Proven Record of Project Delivery.
  • Knowledge of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals (in particular 21CFR Part 11 and Data Integrity requirements).
  • Strong problem solving with experience in RCPS being advantageous.
  • Strong continuous improvement and lean methodology mentality.
  • Be hard-working with excellent communication and partner management skills.
  • Acute attention to detail.

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