Material Qualification
Baxalta
Lessines, Belgium
4 dagen geleden

Responsibilities

  • 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, )
  • Profile :

  • 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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