- A vacancy has arisen for the role of a Quality Control (QC) Instrumentation Systems Specialist at our client’s busy pharmaceutical site in Dublin.
- The successful candidate will operate 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.
- The Quality Control group ensures all materials used for their products is manufactured, processed, tested, stored, and distributed aligned with their incredibly high standards of quality, meeting all regulatory requirements.
- Partnering across the internal manufacturing facilities, external contract manufacturers and suppliers they create a global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.
Core Duties and Responsibilities:
- 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 they maintain best practices and build excellence into their 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.
Minimum Qualifications and Experience:
- Typical Minimum Education: A bachelor’s degree in Engineering, biological science, or related field.
- Minimum 3 years’ experience in CSV and/or CQV for laboratory systems and instrumentation
- Experience in regulatory audits.
- Working knowledge of biologics analytical methods and specifications and Good Manufacturing Practice (GMP).
- 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 skill.
- Ability to prioritize Lab Systems activities in line with the project schedules and business needs.
- Experience and understanding of the change management requirements of validated systems and software.
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
14 Danville Business Park, Kilkenny, Ireland
+353 56 77 90100
Please note, we do not require agency assistance with this role.