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Job Description
About the role:
How you will contribute :
Ensure that all in-process samples, raw material and final products are analyzed in accordance with SOPs and regulatory requirements to applicable GMP’s and standards.
Enforce all laboratory policies and practices
Enforce all safety and security policies and practices
Monitor the testing techniques and the accuracy and completeness of all records and documentation
Solve problems concerning lab equipment and methods
Ensure the calibration and maintenance of the lab instruments
LIMS disposal as backup
Drive continuous improvement in the lab (5S)
Manage deviations and investigations
Initiate and support Corrective and Preventive actions in the laboratory
Perform change assessment
Ensure audit readiness in laboratory, subjects preparation and presentation during audit
Ensure the training of the lab analysts
Perform QC new analyst assessment between the first practice and the first year of arrival
Supervise and participate to the validation activities of the laboratory:
Ensure timely availability of required testing capabilities and supportive documentationEnsure that the status of equipment and procedures are compliant
What you bring to Takeda :
Bachelor’s or Master’s degree or 10 years in the pharmaceutical
Organisation Skills – Ability to manage multiple priorities and know when to escalate issues for resolution.
An understanding of GMP, ICH, USP and global compendia regulations and guidance's.
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, 5S etc)
Good knowledge of FDA, EMA, ICH regulations and Quality system standards
Knowledgeable in inspection against Regulatory / Quality standards
Good computer skills
Fluent in French and English (B2 written and spoken)
What Takeda offers you :
Competitive salaries.
Full accident coverage.
Participation in health insurance premiums.
Advantageous pension plans.
Subsidised meals.
Financial participation in employee sports activities.
Transport: support for local public transport passes, free parking, car sharing programme.
Takeda Neuchâtel offers its employees an attractive working environment and conditions. The well-being, safety, development and career advancement of its employees are at the heart of our vision and our Human Resources, Health, Environment and Safety policies.
Takeda Neuchâtel is an employer committed to its employees and to future generations.
Learn more about Takeda Neuchâtel:
With over 700 employees, Takeda Neuchâtel is one of the ten largest employers in the Canton of Neuchâtel and one of the leading biopharmaceutical production sites in Switzerland. Operating 24 hours a day, 7 days a week, the site
employs a wide range of professionals trained in biotechnologies and their
application in industrial production.
With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted and committed to its local ecosystem.
Takeda Neuchâtel is certified as a training company by the Swiss State Secretariat for Economic Affairs. We train young apprentices in various fields such as laboratory quality control, logistics, IT and biopharmaceutical production.
“Empowering our people to shine”:
Takeda is proud of its commitment to creating a diverse workforce and
providing equal employment opportunities to all employees and job applicants without regard to skin colour, religion, gender, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status or any other characteristic protected by law .
Locations
CHE - Neuchatel
Worker Type
Employee
Worker Sub-Type
Fixed Term (Fixed Term)
Time Type
Full time