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].
#J-18808-Ljbffr