Reg Affairs / Compliance QC Specialist
The role of a Reg Affairs/Compliance QC Specialist is to ensure the quality and compliance of our X-ray and MRI contrast media products.
Description
Our company manufactures and distributes X-ray and MRI contrast media for internal and external customers worldwide. As part of our Pharmaceutical Diagnostics (PDx) business, we support the PDx vision of being the best-in-class supply chain delivering the right dose to the right patient at the right time. Our campus in Co. Cork employs approximately 600 staff and operates 24/7, exporting to 93 markets worldwide.
This opportunity is for a skilled QC Specialist to join our team that manufactures and distributes X-ray and MRI contrast media for customers worldwide.
Main Responsibilities
* Management of pharmacopoeia reviews and resulting procedural changes.
* QC representative for Regulatory assessments.
* QC support for method transfer.
* Support method validation activities through writing and executing protocols.
* Complete review and approval of validation documentation for other team members on request.
* Provide leadership, coaching, and mentoring for the QC Specialist Team.
Compliance
* System documentation including SOPs, protocols, Validation lifecycle/CSV documentation.
* Ownership of quality systems actions (IR's, CAPA, CC) ensuring timely closure and performance trending.
* Act as a technical and compliance liaison between QC Functional team and Operations/Engineering/QA.
* Participation in internal and external audits and active follow up on audit items.
* Identifying productivity and compliance opportunities and driving same to completion.
Qualifications and Experience
* Level 8 degree in Chemistry/Microbiology or in a Science/Engineering subject.
* Familiar with Regulatory and ICH expectations of good laboratory practices, equipment qualification, and maintenance.
* Familiar with QC systems and processes especially LIMS, MODA & Veeva.
* Experienced in data compilation, review, and report generation.
* Experienced in Data Integrity requirements for QC.
* Project Management - leading & oversight as well as contributory role.
Skills Required:
* Highly attentive to detail.
* Self-motivated, goal-driven person.
* Experienced in technical problem-solving.
* Good organisational skills.
* Strong ability to perform, challenge, and positively influence in an interactive team environment.