QA Specialist
Founded in 2012, EyeD Pharma is a clinical stage pharmaceutical company dedicated to improving the life of patients suffering from ophthalmic diseases with unmet medical needs such as glaucoma or dry eye. We develop innovative therapeutic solutions based on sustained release polymeric micro-implants and inserts.
To support its development, EyeD Pharma is hiring a QA Specialist
Your responsibilities
The QA Specialist is responsible for enforcing quality regulations in all aspects of business as well as providing guidance on compliance matters. He/She will be responsible for the adherence of the assigned EyeD Pharma’s R&D programs to EyeD’s QMS.
- According to the guidance given by the QA R&D Manager, develop and maintain EyeD’s quality management system (QMS) to ensure compliance with the applicable regulatory requirements and standards.
- Participate in the implementation of quality plans and improvement programs through ownership of actions.
- Work closely with R&D team to provide expert compliance information, manage identified issues, and support continuous improvement.
- Advise core teams independently for routine compliance inquiries.
- Ensure assigned deliverables are issued with the required quality level and within the defined delays.
- Assist in readiness preparation, and/or directly support regulatory agency inspection or notified body audit and assist in coordination of response to any findings.
- Participate in the management of suppliers lifecycle (e.g. qualification, audit, event management).
- Ensure that deviations, complaints, CAPA plans and change controls are reviewed and managed correctly and on time.
- Understand complex technical issues and assess their potential impact on product, process or regulatory compliance. Escalate issues based on their impact.
- Participate in risk management activities.
- Lead local and/or cross-functional improvement projects to ensure compliance with regulatory requirements or to improve process efficiency.
- Perform internal audits and participate in supplier audits.
- Evaluate, write and/or review operating procedures (e.g. SOPs), and perform other activities in support of an integrated cross-functional QMS.
- Train staff according to the area of expertise.
- 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 legislation and guidelines, and assess their 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 (chemistry, biology,…), engineering, pharmacy or equivalent
- Minimum 5 years relevant experience in quality assurance in medical device environment is a must, a relevant experience in pharmaceutical environment is an asset
- Good knowledge of the medical device and pharmaceutical industry’s standards, regulations, legal requirements. Knowledge of ISO 13485, risk management tools and GLP.
- Experience in project coordination.
- Fluent in English.
- Strong verbal and written communication skills.
- Agility to manage priorities and deadlines with autonomy.
- Problem-solver with strong analytical skills, result-oriented and assertive.
- ‘Open’ thinking and flexibility.
- Interpersonal and facilitation skills.
- Proactive and willing to work in a start-up environment.
- Adhere to company’s values: team spirit, care, integrity, efficiency.
What we offer
- A permanent position in an innovative and dynamic and fast growing company
- Full time
- Liège, Belgium
