QC Instrumentation Specialist

Role Description

· The role of Quality Control (QC) Instrumentation Systems Specialist at Dublin operates as part of a dynamic team to plan, execute, and managing the activities required to maintain the testing infrastructure of the QC lab.

· The team working style is one of collaboration, coaching, and teamwork to provide Quality oversight and expertise to the QC team to support a High Performing Organisation.

· Our Quality Control group ensures all materials used for our products is manufactured, processed, tested, stored, and distributed aligned with our incredibly high standards of quality, meeting all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

· The QC Instrumentation Specialist roles and responsibilities include but are not limited to the following:

· Responsible the qualification, maintenance, and/or integration of the QC systems, 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 continued compliance for the QC systems and instrumentation

· Support the QC department for troubleshooting, investigations, and deviations as an SME.

· Manage deviations, CAPA's and change control's related to the QC and team priorities.

· Assist with implementation of Quality Chapters to ensure we maintain best practices and build excellence into our QC systems and processes.

· Author and revise local SOPs, work instructions, and guidelines.

· Serve as an SME 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.

· Typical Minimum Education:

o A bachelor's degree in Engineering, biological science, or related field.

o Typical Minimum Experience:

o 3 years' experience in CSV and/or CQV for laboratory systems and instrumentation

o Experience in regulatory audits.

o Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).

· Technical:

· Strong CSV experience with analytical instrument qualification and computer systems implementation.

· Excellent understanding of data integrity compliance requirements

· Demonstrated ability to drive complex tasks to completion.

· Strong organizational, problem-solving, and continuous improvement skills

· Business:

· Ability to prioritize Lab Systems activities in line with the project schedules and business needs.

· 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.

· Leadership:

· Ability to handle multiple projects and deliver on critical deadlines

· Demonstrated ability to work independently on own initiative and manage time

· Demonstrate ability to work with a team and co-ordinate work to meet a common goal.

· A high level of self-motivation, knowledge, enthusiasm and drive.