Regulatory Compliance Specialist

2 weeks ago

Cork, Cork, Ireland beBee Careers Full time

As a skilled Regulatory QC Specialist, you will be part of a team responsible for manufacturing and distributing X-ray and MRI contrast media for customers worldwide.

The ideal candidate will have a Level 8 degree in Chemistry, Microbiology, or a related Science/Engineering subject and knowledge of regulatory and ICH expectations, good laboratory practices, equipment qualification, and maintenance.

Key responsibilities include managing pharmacopoeia reviews and procedural changes, acting as a QC representative for regulatory assessments, and providing leadership, coaching, and mentoring for the QC Specialist team.

Additional responsibilities include maintaining system documentation, owning quality system actions, and participating in internal and external audits.

Requirements include high attention to detail, self-motivation, strong technical problem-solving skills, and good organizational skills. The ideal candidate will also have project management experience and ability to perform, challenge, and positively influence within a team environment.

This is an exciting opportunity to join a dynamic team and contribute to the success of our organization.

  • 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.

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