Grow with us - Your Responsibilities
Ensure that each change is performed in compliance with the change management process as per the process definition,
Collaborate with change control contributor (Quality Engineering, PLCM (MSAT), ONS) to prepare gate meetings, with the target of submitting the change to the validation of the Change Control Committee,
Lead the Change Control Committee
Take decision on quality requirements related to the change control management or escalate to Quality management in case of critical situation, derogation to process or drift in change management process,
Communicate with customers during audits.
Implement improvements to the change management process at procedure, instruction and form levels,
Provide training about Change management process to the stakeholders of changes or colleagues requiring access to change control information.
Leads or participates to non-conformities investigation and definition of CAPA plan,
Leads or participates to continuous improvement projects/initiatives related to Quality, Change management and technical data management,
Develop and maintain the documentation system with a high level of clarity, legibility.
What will convince us
Master degree in Science, Engineering or related field
Minimum 5 years related experience required
Knowledge of requirements and relevant industry standard practices with a demonstrated ability to interpret these regulations to ensure proper implementation in the quality systems
Knowledge of quality systems and product/process lifecycle management within a manufacturing environment
Proficient computer skills required
Excellent communications skills both written and oral, including ability to navigate potentially challenging situations
Ability to quickly assess assigned task requirements, identify potential challenges, and communicate effectively in order to expedite the successful execution of assigned work
Efficient organizational skills, including the ability to manage multiple processes and priorities effectively
Good command of spoken, written English
About Sartorius
Sartorius is part of the solution in the fight against cancer, dementia, and many other diseases. Our technologies help translate scientific discoveries into real-world medicine faster, so that new therapeutics can reach patients worldwide.
We look for ambitious team players and creative minds, who want to contribute to this goal and advance their careers in a dynamic global environment.
Join our global team and become part of the solution. We are looking forward to receiving your application.
www.sartorius.com/careers
Skills Required
- Master degree in Science, Engineering or related field
- Minimum 5 years related experience
- Knowledge of regulatory requirements and industry standard practices with ability to interpret and implement in quality systems
- Knowledge of quality systems and product/process lifecycle management in a manufacturing environment
- Proficient computer skills
- Excellent written and oral communication skills, including handling challenging situations
- Ability to quickly assess tasks, identify challenges, and communicate to expedite execution
- Efficient organizational skills to manage multiple processes and priorities
- Good command of spoken and written English
What We Do
Sartorius is a leading international partner of life sciences research and biopharmaceutical manufacturing. We help our customers #SimplifyProgress from drug discovery to manufacturing so that more people can have access to better medicine. With this, we are #PartOfTheSolution in the fight against diseases worldwide. With innovative laboratory instruments and consumables, the our Lab Products & Services division focuses on laboratories performing research and quality control at pharmaceutical and biopharmaceutical companies as well as academic research institutes. The Bioprocess Solutions division, with its broad product portfolio focusing on single-use solutions, helps customers manufacture biotech medications, vaccines, and cell and gene therapies safely, rapidly, and economically. Based in Göttingen, Germany, Sartorius also has a strong global reach with around 60 production and sales sites worldwide. We regularly expand our portfolio through the acquisition of complementary technologies. In 2023, Sartorius generated sales revenue of around 3.4 billion euros. Currently, around 14,600 employees from around 110 nations are working for customers around the globe. Join our team, partner or collaborate with us.
