Quality Assurance Specialist Raw Materials & Warehouse
Job ID R0026173 Date posted 12/29/2020
Location Neuchâtel, Switzerland
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Job Description
Takeda is the world’s leading rare and complex disease biotechnology company. Our efforts are aimed at developing the best medicines, many of which are already available in more than 100 countries. Our main therapeutic areas include hematology, immunology, lysosomal overload diseases, other genetic abnormalities or diseases, neuroscience, gastro-gastroenterology, internal medicine and, now increasingly, oncology.
QUALITY ASSURANCE (QA) SPECIALIST
Within the Neuchâtel production site (approx. 650 employees), in the hematology sector, we are looking for a Quality Assurance Specialist.
Your mission
This position is responsible for supporting routine GMP (Good Manufacturing Practices) activities and Takeda projects. He / she will ensure the quality of information in systems and documentation regarding current guidelines, compliance and regulatory requirements.
Main responsibilities
- Participate in daily activities related to the review of batch records of raw materials and associated data for batch release (including entry into store)
- Participate in the review and evaluation of change requests according to the procedures, methods, quality systems and applicable regulatory files to meet the requirements of the head office, divisional and regulatory
- Provide support for the resolution of problems / causes at the origin of deviations and CAPA, as needed
- Provide a field presence in the store, in the sampling and weighing area to ensure that the areas and activities comply with cGMPs.
- Provide support for various administrative tasks (planning, documentary monitoring, etc.)
- Promote and participate in continuous improvement
- Actively participate in the implementation of site projects in accordance with regulatory requirements and the Quality department, as needed
- Participate in the implementation of inter-site projects related to raw materials
Required profile
- Ideally 2-3 years of experience in the pharmaceutical or medical device industry.
- Holder of a CFC or HES or university degree in Engineering, Biotechnology, Pharmacy or Quality Management applied to industrial processes or equivalent experience in pharmaceutical and / or biotechnological companies. Experience in quality control (QC) will also be considered.
- Knowledge of the work environment in a controlled atmosphere area
- Knowledge of the rules of Good Manufacturing Practices (cGMP) and Eudralex
- Good verbal and written communication in French
- Good written communication in English (read and written)
- Method and rigor in the work with an ease of analysis of technical problems
- Availability and flexibility with a strong team spirit
- Dynamic and determined character
Takeda-isme
Our values serve as a compass. The “Takeda-ism” gives us a solid foundation for upholding our mission of improving the lives of patients, by behaving with integrity in all we do on behalf of and for the patient.
- Integrity
- Equity
- Honesty
- Perseverance
Our priorities
We make decisions according to our four priorities, in this order:
Put the patient in the centerGenerate trust with societyStrengthen our reputationDevelop our activities
Locations
CHE – Neuchatel
Worker Type
Employee
Worker Sub-Type
Regular
Time Type
Full time
Job ID R0026173
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