UniD is a Contract & Development Manufacturing Organization (CDMO) dedicated to micro and macro implants for the controlled release of drugs. Its brand-new facility with its tailormade equipment & technologies allows to handle extrusion, co-extrusion as well as injection moulding-based products. Clients can benefit from unique services going from Proof of Concept to commercial manufacturing. To provide quality support and advice to operational teams and meet customer’s expectations, UniD is hiring a QA Specialist.
Your mission:
The QA specialist's mission is to act as a quality referent for the different operational departments, and to support day-to-day quality activities. His mission is therefore to ensure that quality rules are applied in all aspects of the business, and to provide advice on compliance questions. Finally, he ensures that assigned programs/projects adhere to the entity's quality management system.
Your responsibilities:
The QA Specialist is responsible for the following:
* Maintain the quality management system (QMS) to ensure compliance with the applicable regulatory requirements and standards, as well as any communicated requirements (e.g. EHS, customer, internal).
* Work closely with operational teams (e.g. clinical, non-clinical, CMC, QC…) to provide expert compliance information, manage identified issues, and support continuous improvement.
* Advise core teams/project 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, notified body or customer audit.
* Assist in coordination of response to any findings.
* Participate in the management of suppliers lifecycle (e.g. qualification, audit, event management).
* Ensure that deviations, LIR, 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 and defined relevant mitigations.
* Perform trend analyses and raise appropriate conclusions and actions in relation to product characteristics or more technical aspects (equipment performance, clean utilities monitoring, environmental monitoring, etc.).
* Lead local and/or cross-functional improvement projects to ensure compliance with regulatory requirements or to improve process efficiency through ownership of actions.
* 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.
* Ensure documentation and training system administration.
* Generate and provide metrics, status and trend reports and other QMS-related information (Deviation, LIR, Training, etc.), 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.
* Change driver, participates in the continuous improvement culture and identifies opportunities to simplify processes in collaboration with other departments
* Represent QA department in any assigned meeting
* Ensure QA oversight on the floor, as relevant for the assigned activities
* Practice safe work habits and adhere to safety procedures and guidelines.
Your profile:
* Master in Sciences (chemistry, biology,…), pharmacy or equivalent by experience.
* At least 5 years’ experience in the pharmaceutical and/or medical device field, ideally in a quality function
* Good knowledge of the medical device and pharmaceutical industry’s standards, regulations, legal requirements, including ISO 13485.
* Knowledge of risk management tools.
* Fluent in French and English (written and spoken)
* Advanced computer skills in MSOffice applications and experience using enterprise systems (eg ERP/eQMS/LIMS,…).
* Agility to manage priorities and deadlines with autonomy within the assigned projects
* Rigorous and assertive
* Good communication skills and ability to manage interactions with multiple departments or customers/suppliers
* Problem-solver with strong analytical skills and a risk-based approach
* Ability to adopt a project management working style
* Proactive and willing to work in changing environment
* Knowledge of GLP and/or GCP is an asset
* Being eligible as QP is an asset
* Adhere to company’s values: team spirit, caring, integrity, efficiency, empowerment.
UniD Manufacturing offers:
* A permanent position in an innovative and dynamic and fast-growing company.
* A fulltime job
* Location in Liège
Please send your CV to: job@eyedpharma.com