16958 – Quality Control Specialist – Dublin Contractor

This is an 11 Month Contract with a view to extension.

Purpose

The QC Laboratory Systems team member is responsible for the routine maintenance and calibration of quality control instrumentation and software systems.

Responsibilities

• Responsible for maintaining the routine maintenance calibration of Quality Control instrumentation, in compliance with up-to-date data integrity, regulatory, and industry standards.
• Responsible for change control process and mechanisms required to maintain a state of continuous compliance for the Quality Control instrumentation (e.g. Instrument Software/Hardware upgrades).
• Support the Quality Control department for troubleshooting, investigations, and deviations as a Subject Matter Expert.
• Participate in deviations, CAPA’s, and change controls related to the Quality Control instruments and team priorities.
• Assist with implementation of our company Quality Chapters to ensure we maintain best practices and build excellence into our Quality Control systems and processes.
• Author and revise local SOPs, work instructions, and guidelines.
• Provide support for regulatory and internal inspections and audits.
• Motivation to be an inspiring member of a high-performing team with the desire to continuously learn, improve, and develop.

Requirements

• Level 7 or level 8 in Engineering, science, or related field and/or proven work experience as stated.
• Proven experience in CSV and/or calibration for laboratory / analytical instrumentation
• Experience in regulatory audits and preparation for inspection.                    • Working knowledge of laboratory analytical methods and Good Manufacturing Practice (GMP).
• Practical understanding of data integrity compliance requirements
• Demonstrated ability to drive multiple tasks to completion.
• Strong organizational, problem-solving, and continuous improvement skills
• Ability to work with external vendors
• Ability to maintain the flexibility to react to changing business needs
• Experience and understanding of the change management requirements of validated systems and software
• Excellent communication skills both verbal and written.