QC Analyst

Website Kyron Innovative Technologies

We have a fantastic QC Analyst opportunity for candidates interested in a new challenge in a cGMP regulatory environment. Join a supportive, growing team in the analysis of Biologics and Vaccines in a new state of the art Quality Operations laboratory in Carlow involved in the manufacture and test of our client’s biggest selling vaccine product.

Your Role: The QC Analyst will help in the start-up of this laboratory and complete analytical method transfers and validation as well as routine testing. At this time, the team is working a shift pattern and may divert back to day hours in the coming months. 

2 Cycle Shift Pattern

  • Morning (7am -3pm Mon-Thu, 7am-2pm Friday)
  • Evening (3pm-11pm Mon-Thu, 2pm-9pm Fri)

The role reports to: QC Chemistry Manager.

Location: Carlow

EU Work Permit essential

Length of contract: 11 months, full time

Salary:  €40-45k

Job Responsibilities:  

  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Work as directed by the Quality Control Manager according to Company safety policies, cGMP and cGLP. Required to drive compliance with Global policies, procedures and guidelines and regulatory requirements and execute Good Manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.
  • Participate in QC Tier 1 daily meetings and ensure effective communication of testing progress, deviations etc.
  • Participate in writing/revising/ rolling out accurate operational procedures, training materials and maintenance procedures for various Quality systems; ensure all work is carried out in line with same.
  • Operate as part of the QC team performing the allocated testing and laboratory based duties.
  • Perform various analytical techniques including but not limited to HPLC/UPLC, (HIC, CE, IEX, HP-SEC), Capillary Electrophoresis and other compendial test methods in compliance with GMP requirements
  • Peer review testing documentation and ensuring data integrity compliance and QC Right First Time KPIs are achieved.
  • Participate in the laboratory aspects of OOS investigations.
  • Provide support with audit/inspection requirements to ensure department compliance/readiness.
  • Participate in internal and external audits and inspections, taking the role of auditee for assigned areas of responsibility.
  • Drive continuous improvement, perform root cause analysis on system failures and substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc,
  • Work collaboratively to drive a safe and compliant culture.

Minimum Requirements

  • Bachelors’ Degree or higher preferred; ideally in Analytical Chemistry/ Biochemistry or a closely related discipline.
  • 2-3 years of experience in a pharmaceutical laboratory.
  • A good working knowledge of HPLC systems and software is desirable.
  • A good knowledge of cGMP, GLP, Quality Management Systems.
  • Method validation and method transfer experience would be Advantage.
  • Candidates must be eligible to work in the EU.

Initial Travel Requirements:

  • Occasional travel may be required for training purposes.

About Kyron Innovative Technologies

We are a preeminent provider of ‘Building in Quality’ in Europe, we deliver the Safest, Leanest and Highest Value-added project Quality and Commissioning services by thinking and acting Innovatively, Efficiently and Ethically in everything we do. Our clients in the Semiconductor, Pharmaceutical and Data Centre sectors rely on us to ensure that their new or existing facilities operate at peak performance. 

To apply for this job email your details to hrdept@kyronit.com