The main responsibility of the Quality Specialist is to work with the team and key stakeholders including Customer Service Operations, IICC (Inbound, Inventory, Compliance, Controlled Substances), Customs and ICMD (Intercompany Master Data) to ensure that all products physically and / or financially owned by company are released for sale to global markets in accordance with the EU GDPs.
The role has accountability for the implementation, execution, monitoring and compliance of the Quality Systems in support of the release for sale activities.
Operational Quality (90%)
Review, evaluate and support complex investigations and present formal notifications of significant issues to senior management and Quality Review Teams.
Ensure fulfillment of local legal regulations.
Ensure that the provisions of the license are observed.
Ensure that the operations do not compromise the quality of medicines.
Ensure monthly metrics are gathered and communicated in a timely way.
Support for the GDP licenses responsible for as notified to the respective BoH :
Ensuring that a quality management system is implemented and maintained
Focusing on the management of authorized activities and the accuracy and quality of records
Ensuring that initial and continuous training programs are implemented and maintained
Coordinating and promptly performing any recall operations for medicinal products
Ensuring that relevant customer complaints are dealt with effectively if applicable
Ensuring that suppliers and customers are approved
Approving any subcontracted activities which may impact on GDP
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place
Keeping appropriate records of any delegated duties
Deciding on the final disposition of returned, rejected, recalled or falsified products
Approving any returns to saleable stock
Ensuring that any additional requirements imposed on certain products by national law are adhered to.
Project Support and Continuous Improvement (10%)
Improve daily activities linked to operational quality based on metrics and stakeholder feedback
Bachelor’s degree and 5 years working experience in a quality environment
French or Dutch and English (spoken and written)
Experience in Quality administered systems.
Excellent system skills Word and Excel essential, experience with electronic documentation control systems
Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation.
Knowledge of drug regulations and regulatory guidance of FAMHP and other leading agencies (EMA, FDA) is a strong asset.
Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
Insight and understanding of shareholders needs and requirements.
Dynamic, flexible, enthusiastic, and eager to learn.
Takes initiative and ownership to deliver on time without compromising on quality.
Ability to work under minimal supervision and in a team.
Able to demonstrate good planning and organization skills.
Ability to apply technical knowledge and understanding to making appropriate and timely risk-based decisions.
High level of self- integrity and ethical conduct
Excellent Quality Decision making skills.