ICON Clinical Research QA Specialist II in Dublin, Ireland
The a successful QA Specialist will assess and support the quality practices surrounding the computer system development lifecycle at ICON, as well as conduct internal & external audits in order to assure compliance with applicable requirements (such as ICONs SOPs, regulations and guidance documents), with particular responsibility for audits related to computer validation systems, corrective and preventive actions and provide audit support during inspections.
Understand risk management and be able to apply practical, focused solutions to SDLC and Operational problems in order to remain compliant with regulations while aligning with business needs.
Assist Development Team in sustaining process, QMS and regulatory compliance of any new products or features being brought into the ICON NPI process in accordance with appropriate cGxP
Development of appropriate quality checkpoints in the NPI process that feeds seamlessly into the SDLC so to maximize efficiency of the overall process and ensure compliance strategy is effective
Travel (approximately 10%) domestic and/or international.
Lead quality problem investigations using proven Quality tools and provide training as necessary to staff with respect to problem resolution, process or procedure changes, thus facilitating the continuous improvement of the documented Quality changes, including any applicable compliance or regulatory requirements
Managing the effective closure of applicable audit findings, CAPAs, and customer complaints by close liaison with record owners to help them conduct adequate root cause analysis and develop an effective action plan
Develops audit records and reports and provides signed statements for inclusion in records and reports
Assist in the facilitation and support of 3rd party audits on the ICON site, including assisting in the effective closure of any observations
Management of internal and supplier audit schedules and of QA Auditors, to ensure ongoing ; compliance with the documented QMS, addressing quality metrics, assessing the quality status of other functions, continual improvement of the auditing process and its effectiveness within the QMS, mentoring of QA auditors to deliver high end audit discipline
Provide feedback and reports to senior management on a regular basis, in particular through the weekly quality metrics reports
Understand key business drivers and uses this understanding to accomplish own work
Skills & Experience Required
Prior relevant quality assurance experience in pharmaceuticals, biotech or CRO fields
Requires expanded practical and conceptual knowledge in own discipline and broadened capabilities
Able to work with teams independently
Working knowledge of current cGxPs (GLP/GMO/GMP/GCP, ICH and QA principles, 21CFR Part 11 and auditing against the regulation
Working knowledge of SDLC methodology and ability to audit systems against required deliverables of the methodology in use and applicable regulations and/or computer system validation (CSV)
Project management skills
Business computer skills
Explains complex information to others in straightforward situations. Problem solving skills: ability to solve problems where technical expertise and knowledge of precedents enables identification of possible solutions and underpins making of judgment
Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employees location, the employee may be required to possess a valid
- University/Bachelors Degree/Diploma in life science, business administration or local equivalent qualification/relevant work experience.
Benefits of Working in ICON:
ICON enjoys a strong reputation for quality and is focused on staff development. We make it our mission to attract the most diverse and creative minds into the business and we continually strive to provide opportunities for our people to excel, grow and build a great career. We understand that our greatest asset is the skills and talents of our people and they are truly what set us apart.
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage. We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment