Quality Assurance Expert

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism - Integrity, Fairness, Honesty, and Perseverance - and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.

Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives - including your own.

An exciting and challenging opportunity has become available at Takeda’s Neuchatel Manufacturing plant (approx. 650 employees) for an experienced **Q**uality Assurance Expert - Quality Control & Receive, Release and Deliver.**

**About the role**:
As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight related to activities throughout the laboratory, supply chain & warehouse processes.

The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities as well as for improvement initiatives for his/her department. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements. Participation in GMP zone audits as well as internal and external regulatory inspection is an integral part of his/her activities. The QA expert is accountable for the promotion of continuous improvement and involved related initiatives.

**How you will contribute**:

- Lead and/or review deviations in the framework of raw material management as well as product and environmental QC testing (physicochemical, biochemical and microbiological) events within quality systems (i.e., Trackwise) 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 CAPA.
- Evaluate internal changes and/or external change requests from suppliers and follow deployment through change control according to procedures, GMP requirements and regulatory licenses.
- Prepare, evaluate, and approve controlled documentation revision.
- Provide support to raw material release and external Drug Substance reception.
- Review and evaluate Material Qualification for chemicals and Transportation Qualification for Neuchatel site.
- Participate and/or lead improvement initiatives and enhancement projects.
- Perform GMP Tour of laboratory and warehouse areas.
- Participate in external regulatory agency inspections, observation responses and regulatory submission preparation as required.
- Participate in day-to-day operational decisions as needed.
- Report out of findings/issues to functional leaders and higher management as needed.
- Inspection and Release of raw material and external BDS.
- Ensure Release planning is up to date.
- Participate to the feeding of the KPI of release of raw materials.
- Ensure activities associated with the archiving as required.

**What you bring to Takeda**:

- Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy or “Quality Management” applied to industrial process.
- 2-5 years of experience within a GMP environment, biotech/pharmaceutical company.
- Background in QC GMP testing on biopharmaceutical products.
- Knowledge of FDA, EMA, ICH, Pharmacopoeia 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).
- High affinity to digital technology.
- Autonomous, structured, rigorous and self-motivated.
- Solution oriented, pragmatic, ability to simplify complexity.
- Able to manage priorities in a fast and dynamic environment with a strong emphasis on maintaining high quality standards.
- 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.
- Oral and written skills in English and French, fluency is an asset.

**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