Scientist in QA Support Functions
Vor 3 Tagen
In your role as a Scientist QA you will be supporting routine quality oversight activities in collaboration with the operational organizational units of local Maintenance & Utilities, Quality Control, local warehouse and internal transports and qualification activities in Opex projects as well as periodic Re-qualification activities. This includes operational quality management according to cGMP to assure appropriate quality of the services provided to the Value Streams, adherence to any applicable CSL standards and procedures, review and approval of related GxP records, non-conformances, investigations, CAPAs, change controls and is aware of the corresponding quality metrics. You will also participates in projects.
**Responsibilities**:
- Partner and support relevant stakeholders in maintenance, utilities engineering, quality control and local warehouse to maintain compliance and adhere to QA standards.
- Provide Quality Assurance oversight supports compliant quality decisions jointly with the stake holders in in the areas of maintenance / utilities, utility monitoring, material management, warehousing and quality control to maintain compliance in the specified areas.
- Periodic quality oversight floor tours in warehouse with warehouse supervisor and Supply Chain with regard to routine operations.
- Management of simple major and minor deviations, leading the team to perform initial risk assessments (SQUIPP), Quality on the Floor support of the investigation, jointly generating deviation reports with the owner to ensure compliance, establishing root cause and defining CAPAs. QA approval/closing of deviations and effective CAPAs and recurrence investigations support.
- Management of changes as “Quality Delegate”.
- Review and provide QA approval for GxP documentation in the specified areas of duty for routine documents.
- Perform GMP training of new employees in QA Support Functions in designated areas according to clear instructions.
- Support preparation of quality investigations and changes presentations to health authorities.
**Position Qualifications and Experience Requirements**:
- Master/PhD degree in relevant discipline (or equivalent)
- 0-2 years or more working in a similar role
- First experience in some of the below areas preferable but not mandatory:
- cGMP and Compliance
- Engineering maintenance operations
- Utility monitoring programs
- Material management and warehousing & logistics
- Quality control & analytical methods
- Change control management
- Deviation management
- CAPA management
- Collaboration skills
- Ability to network across departments to liaise for efficient collaborations
- Capability to communicate technical matters in an understandable, concise and precise form, excellent writing skills
- Fluent German and English (spoken and written)
We offer an efficient training and qualification program, hybrid workplace flexibility (home office & onsite workplace) and competitive compensation package.
**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
**Do work that matters at CSL Behring**:
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