Sterility Assurance Expert

vor 7 Monaten

Basel, Schweiz Takeda Pharmaceutical Vollzeit

**How you will contribute**:

- Lead investigations linked to microbiological deviations and actively lead subsequent corrective actions, where necessary.
- Be responsible for risk analyses defining environmental and utility monitoring strategies.
- Carry out Sterility Assurance assessments of all changes related to his/her associated production area.
- Lead changes related to Sterility Assurance in his/her associated production area.
- Support/lead validation, qualification, and investigation projects in connection with the activities of the Sterility Assurance Department and its associated production area.
- Lead actions to monitor aseptic practices as part of continuous improvement.
- Monitor and analyze environmental and utility trends.
- Maintain and improve quality processes related to Sterility Assurance.
- Participate in regulatory agency audits/inspections.
- Participate in interdisciplinary projects.
- Train and coach site personnel in cleanroom procedures (aseptic training, cleanroom behavior and best practices).
- Encourage new and innovative approaches to improve Sterility Assurance.

**What you bring to Takeda**:

- Advanced scientific training (Master’s degree in Microbiology, Engineering, Pharmacist ).
- At least 5 years of experience in the pharmaceutical industry (preferably in a biologics company) in a GMP environment.
- Excellent knowledge or Eudralex Annex 1 Manufacture of Sterile Medicinal Products.
- Good knowledge of environmental sampling technologies.
- Good knowledge of investigation processes (methodology).
- Proven understanding of continuous quality and process improvement tools (as defined by the site, e.g. DMAIC, 5S, etc.).
- Standard IT and Microsoft Office tools.
- French and English (B1 written and spoken).

**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 employer committed to its employees and to future generations.

**Learn more about Takeda Neuchâtel**:

- With more than twenty nationalities, Takeda Neuchâtel offers an international, diverse and innovative working environment within a company that is firmly rooted 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 various fields such as 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 job applicants without regard to skin colour, religion, gender, 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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