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Regulatory QC Specialist
1 month ago
Reg Affairs / Compliance QC Specialist
This is an opportunity for a skilled QC Specialist to join our team at a leading manufacturer and distributor of X-ray and MRI Contrast Media. As part of the 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.
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/approval of validation documentation for other team members on request.
- Provide leadership, coaching and mentoring for QC Specialist Team.
- 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.
- 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.
- 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.
We are a 24/7 operation exporting to 93 markets worldwide and employ approximately 600 staff at our campus in Co. Cork.
