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Job Description

Primary Duties

This position is within the Quality organization at the Neuchâtel facility and is intended for the Quality Assurance department.

Within this position, QA Expert is responsible for compliance and quality oversight related to activities throughout the manufacturing and release process of Drug Product (DP).

Quality Assurance Expert

• Act as QA representative for both routine GMP (Good Manufacturing Practices) activities and

• Takeda projects ;

• Act as the Quality partner with Production Team, Sterility Assurance group, Quality Control

• laboratories, Warehouse and Engineering departments as applicable ;

• Ensure quality of information reported within systems and documentation with respect to current

• guidelines, compliance and regulatory requirements.

• Support and work in line with the “QA on the shopfloor” team (for example through GMP audits

• or events management).

• Participate in GMP tour as well as internal and external regulatory inspection.
• Shall promote and be involved in Continuous Improvement initiatives.
• Understand and apply Takeda EHS guidelines and commitments policy, take care of its own safety, report risk situations and improvement opportunities to supervisory personnel.

• The job holder can act as back up of other QA Experts/Specialist and QA manager as requested.

Responsibilities

Release activities

• Ensure Release planning is up to date
• Prepare the batches for the QP batch certification
• Ensure activities associated with the archiving as required

Quality in Operations

• Provide quality oversight, i.e. support and guidance to production team units in their

• routine activities directly on the floor, fostering strict application of cGMP concepts and
• quality systems.
• Execute Takeda guidelines and Regulatory cGMP requirements in the respective Quality
• area
• Participate in day-to-day operational decisions as needed, including on-call service.
• Report any potential issue detected on the floor and proposes adequate guidance for
• documentation and correction.
• Establish efficient partnership with production and associate departements (e.g:
• maintenance, engineering, QC, etc-) to define and review detailed action plan for any
• process modification or improvement.
• Participate and/or lead meetings with production and other departments as approriate
• Ensure respect and commitment to EHS guidelines
• Ensure a straight collaboration with the QA on the shopfloor associate;
• Provide feedback on projects and routine activities using proactive communication

Change Controls

• Evaluate internal and/or external change requests (interfacility changes (IFCAs)) and follow deployment through change control according to procedures, GMP requirements and regulatory licenses.
• Act as change approver for routine and emergency changes. This includes performing evaluation, assist, review and prepare corresponding documentation until timely closure of all tasks and change control records.
• Follow the activities associated to the significant material changes

Deviations

• Lead or review and approve deviations in the framework of production and laboratory events within quality systems to verify acceptability and adherence to standard procedures and regulatory requirements. This includes conducting or approving the relevant investigations, impact assessments (related to impact on concerned equipment/product/material) and definition of relevant corrective/preventive actions (CAPA).
• Support all investigations (intersites and all kind of criticity of deviations) related to deviations process and in the area of responsibility.
• Ensure deviation and CAPA management documentation in a timely manner.
• Develop and implement appropriate tools and methods to perform standard investigation and problem solving techniques, to close exception documents, and to ensure appropriate adherence to quality documents (procedure, run sheets, material specification, etc.).
• Assist in performing complaint investigations, as needed.

Documentation:

• Prepare, evaluate and approve new or revised controlled documents (procedures, SOPs, forms, SISA, specifications, etc.) .
• Ensure timely review and implementation of documentation for accuracy and compliance
• Propose continuous improvement of documents in direct partnership with relevant SME.

Compliance

• Perform internal facility GMP audits of manufacturing and support areas
• Participate in external regulatory agency inspections, observation responses and regulatory submission preparation as required
• Execute the Takeda internal facility GMP-Tour

Various:

• Provide training to employees in relevant areas (e.g. GMP, GDP, Batch review, etc.).

• Participate and support activities such as quality documentation approval, RAM approval, training profiles management, archive activities, monthly KPI preparation, annual PQR preparation and other tasks as appropriate.
• Participate and/or lead improvement initiatives and site enhancement projects
• Report out of findings/issues to functional leaders and higher management as needed

Batch Records Review (on request):

• Review batch records according to procedures and guidelines/regulations
• Ensure their timely transmissions to the respective department

Education and Experience:

• Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy, or Quality Management applied to industrial process or equivalent industrial experience
• 2-5 years of experience within a GMP environment, pharmaceutical and/or biotechnological industry
• Ideally demonstrated experience in Quality Assurance

Key Skills, Abilities, and Competencies

Technical skills:

• Knowledge of GMP, FDA, EMA, ICH, Pharmacopeia regulations, quality system standards and data integrity principles
• Knowledge in auditing and inspection against regulatory / quality standards
• Knowledge and interest in detailed manufacturing operations (e.g. engineering designs, automation documentation, biotechnological processes)

Language & IT Skills (Compétences linguistiques et informatiques):

• Fluent in french,
• Intermediate level in English,
• Mastery of MS Office pack
• Knowledge/Experience with Quality tools such as Trackwise, PAS-X

Personal qualities:

• Positive and self-motivated
• Accountable
• Solution oriented, pragmatic, ability to simplify complexity
• Good analytical skills
• Good organizational skills, structured, rigorous, able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high quality standards
• Proactive, autonomous continuous improvement mindset
• Team player, prepared to work in team-based culture including manufacturing personnel on the floor
• Demonstrate excellent communication skills (oral and written), ability to adapt to audience.

Complexity and Problem Solving

• Participate in day-to-day operational decisions as needed, including on-call service, related to pursuing manufacturing and documentation of unexpected events.
• Review and evaluate change requests/deviations according to processes, methods, quality systems and applicable regulatory files.
• In such decisions, the QA expert ensures the compliance and alignment with the Standards Operating
• Procedures, validation reports, licenses, cGMP and relevant regulations.

Internal and External Contacts

• Collaborates across the network and continuous improvement teams across the organisation.
• Collaborates with cross-functional teams to deliver the site objectives

MORE ABOUT US:

At Takeda, we are transforming patient care through the development of innovative specialty medicines and first-class patient support programs. Takeda is a patient-oriented company that will inspire you and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and aims for excellence in everything we do. We promote an inclusive and collaborative work environment where our teams are united by an unwavering commitment to delivering Better Health and a Brighter Future to people worldwide.

EMPOWERING OUR PEOPLE TO SHINE:

Takeda is proud of its commitment to creating a diverse workforce and offering equal employment opportunities to all employees and applicants without distinction of race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, marital status, or any other characteristic protected by law.

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