Regulatory QC Specialist

2 weeks ago

Cork, Cork, Ireland Life Science Recruitment Full time

Reg Affairs / Compliance QC Specialist

Description

My client manufactures and distributes X-ray and MRI Contrast Media for internal and external customers worldwide. As part of the Pharmaceutical Diagnostics (PDx) business, they support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. Located at their campus in Co. Cork, they employ approximately 600 staff and operate 24/7, exporting to 93 markets worldwide.

This is an opportunity for a skilled QC Specialist to join a team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.

Reporting to: Quality Manager

Main Responsibilities

  • Management of pharmacopoeia reviews and procedural changes.
  • QC representative for regulatory assessments.
  • QC support for method transfer.
  • Support method validation activities through writing and executing protocols.
  • Review and approve validation documentation for team members upon request.
  • Provide leadership, coaching, and mentoring for the QC Specialist team.

Compliance

  • Maintain system documentation, including SOPs, protocols, and validation lifecycle/CSV documentation.
  • Own quality system actions (IRs, CAPA, CC), ensuring timely closure and performance trending.
  • Act as a technical and compliance liaison between QC, Operations, Engineering, and QA teams.
  • Participate in internal and external audits and follow up on audit items.
  • Identify opportunities for productivity and compliance improvements and drive initiatives to completion.

Qualifications and Experience

  • Level 8 degree in Chemistry, Microbiology, or a related Science/Engineering subject.
  • Knowledge of regulatory and ICH expectations, good laboratory practices, equipment qualification, and maintenance.
  • Familiarity with QC systems and processes, especially LIMS, MODA, and Veeva.
  • Experience in data compilation, review, and report generation.
  • Understanding of Data Integrity requirements for QC.
  • Project management experience, both leading and contributing.

Skills Required:

  • High attention to detail.
  • Self-motivated and goal-oriented.
  • Strong technical problem-solving skills.
  • Good organizational skills.
  • Ability to perform, challenge, and positively influence within a team environment.

For more information, please contact Alan at 087 365 7522 or [emailprotected].

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