QA Expert

vor 3 Wochen

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**Takeda Neuchâtel**

**Site de Production Biotech | Biotech Manufacturing Site**

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:
**Quality Assurance Expert**

Takeda’s Neuchatel Quality department is looking for a highly motivated **QA Expert **to join the team dedicated to providing quality oversight for operational activities related to purification manufacturing activities of biologic products.

This is an exciting career opportunity for a dynamic, autonomous, rigorous and change agile quality professional to embrace a team-based culture in a world-class Biotech manufacturing environment.

**Your mission**

As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight related to activities throughout the manufacturing and certification process.

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.

**Essential Duties & Responsibilities**
- Review batch records (paper-based and electronic format in MES system)
- Contribute to the batch certification of products
- Lead and/or review deviations in the framework of production 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.
- On-call quality support for manufacturing activities
- Evaluate internal and/or external change requests and follow deployment through change control according to procedures, GMP requirements and regulatory licenses.
- Prepare, evaluate, and approve controlled documentation revision
- Participate and/or lead improvement initiatives and enhancement projects
- Perform internal facility GMP audits of manufacturing and support 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

**Required Skills**:

- 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)
- 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
- Excellent oral and written skills in English and French, fluency is an asset

**Education & Experience**
- 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
- Ideally demonstrated experience in Quality Assurance

**Takeda’s Outstanding Values**

To help us achieve our mission, we believe in focusing on the needs of patients through empowering our teams. Together, we are united by our four priorities (Patients, Trust, Reputation, and Business) and our shared values of **Takeda-ism**: Integrity, Fairness, Honesty, and Perseverance. Takeda-ism is more than just a word. It’s a belief and a mindset which guides our decisions, behaviors, and interactions. It’s how we strive to work and live, every day.

**Locations**:
CHE - Neuchatel

**

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