Quality Control Systems Specialist
CR/077225-1
Posted: 16/04/2025
- Competitive
- Ireland, County Dublin, Swords
- Contract
Orion Group Life Sciences are currently recruiting a Quality Control Systems Specialist on behalf of our Multinational Biopharmaceutical Client based in Dublin on an initial 12-Month contract with potential to extend.
This is a Monday – Friday On-Site Role
Role Description
The Quality Control (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 as a whole (installation, qualification, operation, and retirement).
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 requirements to ensure compliance, safety, and reliable supply to our customers.
Role Functions
(Functions include, but are not limited to, the following)
The QC Maintenance Instrumentation Specialist roles and responsibilities include but are not limited to the following:
Experience, Knowledge & Skills
Technical:
Business:
Leadership:
Qualifications:
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
This is a Monday – Friday On-Site Role
Role Description
The Quality Control (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 as a whole (installation, qualification, operation, and retirement).
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 requirements to ensure compliance, safety, and reliable supply to our customers.
Role Functions
(Functions include, but are not limited to, the following)
The QC Maintenance Instrumentation Specialist roles and responsibilities include but are not limited to the following:
- Responsible for the 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.
- 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.
Experience, Knowledge & Skills
Technical:
- Strong experience with analytical instrument maintenance, CSV experience beneficial.
- 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 activities in line with the maintenance 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.
Qualifications:
- Third level education in a Science or Engineering related course of study
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
Aoibhinn Daly
Recruitment Consultant
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