Acts as a material qualification representative for small, mid size and big projects within the plant and / or network :
Provides Material Qualification expertise to ensure the success of the project
Defines, prepares and implements all Material Qualification activities related to the project (MQ strategy, documentation approach and structure), in accordance to local and global MQ requirements.
Participates in the risk assessment and in the other qualification / validation activities related to the project.
Prepares and implements Material Qualification documentation, assuring requirements traceability throughout the whole project file (from URS to submission), and the update of the MQ database and documentation.
Organizes and coordinates Material Qualification activities with the different involved departments (on the ground, as required) and contractors, in such a way that all of them concur with the committed project milestones.
Assures open and honest feedback on status and potential risks / issues, with proposal of mitigation / solution to the Process Sciences and MQ Lead and to the Project lead.
Closely collaborates with the MQ stakeholders (Process Sciences, Process / Equipment / Cleaning Validation, Production, Quality, Regulatory, Global MQ, ) to ensure the MQ life cycle from process development, validation, submission to routine production.
Ensures that the Material Qualification status is continuously maintained and improved, following the established local and global MQ strategies.-
Ensures compliance with current GMP and other regulatory requirements and supports corresponding regulatory submission writing and (oral) defenses during regulatory audits.
Provides support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.
Supports or manages deviations and changes in order to guarantee that these are well documented and that corrective / preventative actions are taken and followed-up.
Assures the ability to meet the Department goals with respect to EHS, Quality, Compliance, Supply and Budget fulfillment.
Supports the Process Science and MQ team by working on Process Science activities in the context of improvement projects and problem solving (labscale studies, DMAIC product / process investigations, improvement projects, )
BS or Master Degree in Engineering, Chemistry, Life Science, or other job related discipline or equivalent by experience
At least 2 years professional experience in Material Qualification or similar role
Knowledge of Material Qualification Methodologies, including associated analytical methods and risk assessment tools
GMP and bioprocessing knowledge and experience
Critical thinking and problem solving (DMAIC) skills
Project management experience
Excellent verbal and written communication skills (English)
Honest and responsible, flexible, customer focused, team player, open minded and out of the box thinker
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