Quality Assurance Expert

vor 2 Wochen

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**About the role**:
**The opening for a Quality Assurance Expert at our Neuchâtel facility offers an engaging role within our Quality department. This position focuses on ensuringexemplary Quality Assurance throughout the various stages of manufacturing and product release.**:

- Act as QA representative for both routine GMP activities and Takeda projects.
- Act as the Quality partner within Production Unit Team and the Quality Control laboratories,
- Warehouse and Engineering/Maintenance departments as applicable.
- Ensure quality of information within systems and documentation in respect to current guidelines, compliance and regulatory requirements.
- Support and work in line with the to the “QA on the shopfloor” requirements (for example through GMP audits or events management).
- You will be promoting and will be involved in Continuous Improvement.

**How you will contribute**:

- **Release activities**:ensure Release planning is up to date, prepare the batches for the QP batch certification and ensure activities associated with the archiving as required.
- ** Deviations**:lead or approve “deviations” with in line with to standard procedures and regulatory requirements, support all investigations (intersites and all kind of criticity of deviations) related to deviations process and in the area of responsibility.
- ** Change Controls**:review and evaluate internal change requests or interfacility changes (IFCAs) according to procedures, GMP requirements and licenses and follow the activities associated to the significant material changes.
- ** Compliance/Quality oversight**:execute Takeda guidelines and Regulatory cGMP requirements in the respective Quality area; act as an SME for the QA, participate in internal or external assessments in the respective area, as required, and participate to external audits as required, ensure a straight collaboration with the QA on the shopfloor associate. You will also provide support for regulatory agency inspection and internal audits, closure of observations/audit items and regulatory submissions.
- ** Batch Records Review**:review batch records according to procedures and guidelines/regulations and ensure their timely transmissions to the respective department

**What you bring to Takeda**:

- You possess experience in an GMP environment - it is a must.
- University degree in Engineering, Biotechnology, Pharmacy, and Quality Management applied to industrial process or equivalent experience in pharmaceutical and /or biotechnological companies
- Demonstrate the Takeda Values of Integrity, Fairness, Honesty, Perserverence as a natural way of working.
- Good knowledge of FDA, EMA, ICH regulations, Pharmacopeias and Quality system standards
- Knowledgeable in auditing and inspection against regulatory / Quality standards
- Knowledge/experience with Quality tools such as Trackwise
- You have great skills in analyzing and making complex things easy to understand.
- Focused on finding solutions, listens well, and communicates clear.
- Good at organizing and always looking for ways to do things better.
- French fluent, English read, written and spoken.

**More about us**:

- With over twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted in 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 a variety of fields, including 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 applicants for employment without regard to skin color, religion, sex, 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**:
Regular

**Time Type**:
Full time

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