Material Qualification Specialist
il y a 2 semaines
About the role:
The Material Qualification Specialist, part of the Lessines MS (Manufacturing Sciences) organization, is responsible for performing and coordinating activities linked to Material Qualification:
- Projects within the plant and/or network (e.a. new products / equipment / components)
- Material Lifecycle Management (e.a. changes impacting material qualification, impact evaluation against new requirements)
- Continuous improvement (e.a. new materials improving product quality, process robustness)
- Manufacturing deviations (e.a. root cause investigation and product impact evaluation)
- Regulatory submissions and inspections
- Coordination of MQ activities and day to day guidance for MQ related team (personnel and contractors).
How you will contribute:
- Act as a material qualification representative for small, midsize 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 qualityrelated 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 followedup.
- 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,)
What you bring to Takeda:
- 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
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do.
We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Empowering our people to shine:
- Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status_. At Takeda, we embrace diversity as a whole._
Locations:
BEL - Lessines
Worker Type:
Employee
Worker Sub-Type:
R
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