Qc Supervisor

About the role:

Supervise, in collaboration with the QC Manager the laboratory to ensure reliable and timely availability of test results under cGMP.

This position will be a back up to the Manager in his function of management and documents approval.

Supervise the Quality Control laboratory activities to assure timely availability and accuracy of results.

How you will contribute:

• Ensure that all inprocess 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 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 documentation
• Ensure that the status of equipment and procedures are compliant.

EHS

What you bring to Takeda:

Education, Experience and Competencies:

• Master degree (or equivalent) or 10 years in the pharmaceutical industry, preferably in a Biologics company.

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).
• Enterprise mindset to ensure the right prioritisation in the lab.
• Proven ability around working cross functionally, focusing on meeting and tracking to schedules and embracing an interdependent work culture.
• Good communication with customers and suppliers (external and internal)
• Strong project management skills to support project delivery and operational readiness.
• Excellent trouble shooting and problemsolving skills as well as an ability to coach and mentor selfdirected teams through complex problem solving.
• Ability to challenge the status quo with a continuous improvement mindset.
• Provides leadership and guidance to the QC analyst team
• 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)

Complexity and problem solving:

• Conduct adequate laboratory investigations when issues arise.
• Participate or lead a team when appropriate for the investigation process and manage priorities.
• If necessary and in accordance with the lab manager, initiate and support Corrective and Preventive actions in the laboratory
• Ability to synthesize complex information and to speak confidently in front of an audience

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs.

Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

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:

CHE - Neuchatel

Worker Type:

Employee

Worker Sub-Type:

Regular

Time Type:

Full time

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