As part of the development of the activities of one of our clients, we are looking for a person with experience in Validation in the Pharmaceutical industry.
What about AKKA?
At AKKA, join a community of technology passionate thinkers and doers to partner with the world’s largest industrial groups and make bold innovation happen. Our cross-sector and cross-disciplinary approach will expand your skills and your horizon to infinity.
We are driven by innovation and we are passionate about technologies. We stay at the forefront of the digital and engineering world, and help our clients accelerate innovation, and with our Career Road map, we will offer you the right tools to develop yourself and make your career blossom.
AKKA Benelux is the Belgo-Dutch subsidiary of the international AKKA Group, that employs over 21,000 people in more than 25 countries. AKKA Benelux counts almost 1,000 talented experts in many different sectors and attained a revenue of €69M in 2019.
By the way, we are certified as Top Employer!
Your Responsibilities: Define and implement all validation activities related to the projects. Develop the Validation Plans: define validation methodology and approach. Submit to the Validation Leader for review. Provide validation expertise for the development of the projects. Participate in the risk assessment related to the project. Participate in FS and DS definition and writing Prepare and implement COM, IQ, OQ & PQ protocols Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate COM, IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the validation leader Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon
Your Profile : You have scientific training such as an engineer or a pharmacist. Good communication skills, fluent in english (written and spoken) Familiar with Quality Management and GxP Regulations Has the ability to prioritize multiple tasks and work on multiple projects simultaneously Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP Knowledge of the manufacturing processes
Our Offer :
As an AKKA Consultant, you will be: In charge of diverse transversal and empowering projects Supported in your career by your AKKA Manager Actor of your training plan and your personal and professional development Member of a dynamic and collaborative community of engineers Benefiting from a permanent contract Benefiting from a competitive salary package including several extra-legal benefits.