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.
Operations Validation Specialist
Description of the function:
As Operations Validation specialist you will define and execute validation strategies in accordance with regulatory requirements and in close collaboration with the Quality Unit and the IT validation Expert to ensure compliance of validation activities at Eumedica site.
Your main responsibilities:
• Ensure compliance and assurance for all validation activities on site like equipments, systems, IT, facilities, utilities
• Define and execute the validation strategies in accordance with the regulatory requirements for Eumedica projects as well as commercial and clinical customer projects
• Create the validation documentation regarding the GMP requirements (knowledge of GMP, Eudralex, GAMP, CFR… ) : CSV specific SOPs, user guides, validation protocols, reports, 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 key representative for operational Eumedica projects supporting internal and external audits and inspections
• Promote continuous improvement mindset in the day to day activities
• In close collaboration with the Quality Unit, ensure 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 Operations Validation Specialist, you report directly to the Head of Logistics.
In your role, you will work in close collaboration with Quality Unit, 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).