Quality Control Specialist (Equipment Validation)

  • Cork
  • Permanent
  • JO-1908-64701_1565786627

Summary

Quality Control Specialist (Equipment Validation)

This person is responsible for provision of Validation, Data Integrity (DI) / Computerised System Validation (CSV), Equipment & computerised systems expertise and oversight to the QC department.

Responsibilities:

· Provide leadership and oversight in areas relating to validation lifecycle (IQ/OQ/PQ) / Data Integrity / CSV / IT / within QC & site as required

· Familiar with 21 CFR Part 11/ Data Integrity requirements and implement requirements in a laboratory environment

· Support maintenance/upgrade of laboratory servers and software and support equipment integration activities to the server

· Anticipating and planning for future QC software and systems requirements across the Dept

· Develop the QC team skillset / knowledge base accordingly in relation to best practice implementation of the above

· Fostering an environment of continuous improvement to implement new technologies in QC

· Ensure visibility of, and clear communication on, QC validation activities required for departmental/plant support

· Identify and have oversight of priority CAPEX projects for QC to maintain support to site

· Support QC systems as deemed necessary

Requirements:

· Degree in Science, Engineering or Computer Systems

· Sound technical background in a relevant science/computer science discipline

· Excellent interpersonal and communication skills with proven leadership abilities

· Proven project management skills

· Highly attentive to detail

· Self-motivated, goal driven person

· Experienced in technical problem solving

· Good organizational skills

· I.T. skills and experience of working in a regulated pharmaceutical laboratory environment is essential

· Expertise with respect to DI / Validation Lifecycle / CSV best practices

· Experience in the qualification of HPLC/NIR/ although not required is a distinct advantage

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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