Founded in 2012, EyeD Pharma is a pharmaceutical company dedicated to the development of innovative drug products in ophthalmology. EyeD Pharma is developing innovative products based on a new delivery pathway of well-known drugs with the aim of improving quality of life of patients in various ocular pathologies.
In 2019, UniD Manufacturing was born, which brings together production activities.
In parallel with its R&D and industrialization activities, EyeD Pharma started in 2017 a commercial activity of medical devices (equipment and consumables) for eye surgery.
EyeD Pharma and UniD Manufacturing lay the foundation stone of their future headquarters. This collaborative environment will allow a positive synergy between R&D activities, production, logistics and administration. Our technological platform will be in the Science Park of Liège and will be up and running from 2022.
To support its development, EyeD Pharma is hiring a Quality GCP Officer
Under the responsibility of the QA R&D Manager:
- Maintain the quality system according to GCP requirements in close collaboration with the clinical development department.
- Participate in the development of the audit plan for assigned projects and manage audit plan execution.
- Manage and/or lead GCP audits including but not limited to investigator sites, internal processes, and vendors.
- Work closely with clinical study management teams to provide clinical compliance information, manage identified issues, and support continuous improvement.
- Advise core teams independently for routine compliance inquiries.
- Assist in readiness preparation, and/or directly support regulatory agency inspection.
- Assist in coordination of response to any findings.
- Support deviation identification, reporting, investigation and CAPA plan development.
- Ensure that the monitoring of studies is correctly carried out and support this activity.
- Participate in risk management activities.
- Participate in intra/inter-departmental teams that support operations (e.g. evaluation of a new regulation).
- Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional quality management system (QMS).
- Generate and provide metrics, status and trend reports and other information, as required by management.
- Develop and/or maintain an up to date and in-depth knowledge of appropriate national and international GCP legislation and guidelines; and the impact to assigned business area processes and procedures.
- Foster a commitment to quality in individuals and a culture of quality within the organization.
Your profile :
Master in Sciences with relevant experience in quality assurance.
- Knowledge of ICH-GCP, EU and US regulatory requirements.
- International audit and compliance experience is an asset.
- Fluent in English.
- Proficient in Microsoft Office suite.
- Strong verbal and written communication skills
- Interpersonal and facilitation skills.
- Excellent organization skills and project management
- Able to work equally well as part of a team or independently.
- Proactive and willing to work in a start-up environment.
EyeD Pharma offer
- A permanent position in an innovative and dynamic and fast growing company;
- Full time ;