QC Systems Specialist

Recruitment by Aphex; Fingal; On-site; EUR 65,000 - 90,000; Full time

Job summary

Recruitment by Aphex seeks a QC Systems Specialist to support the QC Laboratory through maintenance, troubleshooting, and repairs of analytical instruments, while managing software applications such as Empower, LabX and Signals. The role leads continuous improvement of QC operations and ensures compliance with site requirements for safety and reliable supply.

Responsibilities include change control, deviations, CAPAs, SOP authoring, and acting as SME for inspections and audits, with strong

Qualifications

• Third level education in a Science or Engineering related course of study.
• 3+ years in Pharmaceuticals.
• Experience with analytical instrument maintenance and CSV is beneficial.

Responsibilities

• Perform planned and unplanned maintenance of QC systems and instrumentation per data integrity, regulatory, and industry standards.
• Lead change control processes to maintain compliance for QC systems and instrumentation.
• Serve as site co-ordinator for Empower, LabX and Signals software applications.

Skills

Data integrity

Problem solving

Organisational skills

Independent working

Team coordination

Education

Science/Engineering degree

Tools

Empower

LabX

Signals

Job description

Purpose

The QC Systems Specialist supports the QC Laboratory through routine maintenance, troubleshooting and repairs of all analytical laboratory instruments, in addition to supporting the instrument lifecycle (installation, qualification, operation, and retirement). Additionally, the QC Systems Specialist supports the management of software application such as Empower, LabX and Signals, and any requests relating to these systems. The QC Systems Specialist leads continuous improvement of QC operations, through their QC Systems knowledge and areas of expertise. The QC Lab System team ensures that QC objectives are effectively achieved and consistent with site requirements to ensure compliance, safety, and reliable supply to our customers.

Responsibilities

• Responsible for the planned and unplanned maintenance of the QC systems and 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 continued compliance for the QC systems and instrumentation.
• Serve as site co-coordinator for software applications such as Empower, LabX and Signals.
• Support the QC department as a Super User and complete method requests as required.
• Support the QC department for troubleshooting, investigations, and deviations as an SME.
• Manage deviations, CAPA's and change control's related to QC systems and instrumentation and team priorities.
• 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

Qualifications

• Third level education in a Science or Engineering related course of study
• 3+ years in Pharmaceuticals

Technical

• Strong experience with analytical instrument maintenance, CSV experience beneficial.
• Experience using software applications such as Empower.
• Excellent understanding of data integrity compliance requirements.
• Demonstrated ability to drive complex tasks to completion.
• Strong organisational, problem-solving, and continuous improvement skills.

Business

• Ability to prioritise activities in line with the maintenance schedules and business needs.
• Ability to maintain the flexibility to react to changing business needs and priorities.
• 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.