EUMEDICA SA is an international reference actor in the pharmaceutical sector. We offer to pharmaceutical companies a wide range of custom-made services in various domains such as regulatory affairs, distribution and promotion of pharmaceutical products as well as tailored logistics services.
Based in Manage, we are looking for talented and dynamic profiles to complete our teams and accompany us in our development.
In this role as QA Validation specialist you will define validation strategies in accordance with regulatory requirements and ensure compliance of validation activities at Eumedica site.
Your main responsibilities:
• Participate in the implementation of the quality systems at Eumedica to ensure compliance and assurance for all validation activities on site like equipment, systems, IT, facilities, utilities
• Define the validation strategies in accordance with the regulatory requirements for Eumedica projects as well as commercial and clinical customer projects
• Define the validation strategies in accordance with the regulatory requirements
• Ensure QA oversight in validation activities (IQ/OQ/PQ...), through CCs, and ensure timely escalation to management of critical issues during validation
• Review/Approve the validation documentation regarding the GMP requirements (knowledge of GMP, Eudralex, GAMP, CFR… ) : CSV specific SOPs and user guides and validation protocols, reports, SOPs, Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic reviews
• Coordinate and execute validation (IQ, OQ, PQ) tests
• Manage deviations and change controls linked to validation activities and projects
• Be the validation representative for the different Eumedica’s projects supporting internal and external audits and inspections
• Key QU contact for some customer projects
• Responsible for defined QU systems
• Promote continuous improvement mindset in the day to day activities within the QU team and peers
• Ensure Quality Systems (deviation, change control, training, documentation, validation SOPs, complaints) are in place and handled in a timely and efficient manner and followed by defined KPIs
As QA Validation Specialist, you report directly to the Head of Quality.
In your role, you will work in close collaboration with Logistics, IT, field support and maintenance departments.
• You have a University degree: Master in Sciences/Engineering e.g. Pharmacist / Chemical Engineer.
• An experience of minimum 5 years in the Pharmaceutical/Chemical/ Food industry with significant experience of GMP
• Validation industrial experience and technical knowledge of computerized systems is an asset
• Relevant experience in Project management
• Analytical and reporting skills : capacity to analyze information and suggest action plans - monitor various KPIs
• Solution oriented: dealing with Complex problems and emergencies and suggest solutions
• Able to work under pressure, manage large workloads and deal with challenges in a professional manner.
• Communication is one of you strengths and you are a good teamplayer
• Experience in Small and Medium size companies (CMO is a plus)
In addition, you have a very good knowledge of IT tools and are fluent in English and French (Dutch is a plus).
• A full time job with a long term contract
• A salary package matching your competence,
• A dynamic and ambitious environment with possibility to develop your skills.
Operational site in Manage (near Nivelles, easy to reach by car).