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Quality Assurance Team Lead and Quality System Team
vor 2 Wochen
Bacthera is leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and
Switzerland. We bring together best-in-class, complementary capabilities and we are the first
CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.
For our site in **Visp (Switzerland) **we are seeking two dynamic, open minded and talented
**Quality Assurance Team Lead (f/m/d) 100% and**
**Quality System Team Lead (f/m/d) 100%**
Both team leads are member of the global Quality Assurance and Quality System team and play an essential role in the implementation of Quality capabilities to support our commercial manufacturing site. The roles ensure the guidance and hands-on Quality oversight for the GMP operation department according to the procedures and GMPs requirements. He/She will report to the Global Head of Quality Assurance or the Global Head of Quality System. Be part of a highly motivated and fast-growing team and shape the structure of the Quality Assurance
Team or the Quality System Team.
**Role and Responsibilities**
- Lead the Bacthera Quality Assurance/Quality System Team in Visp
- Be the first contact for the manufacturing operation team within quality related issues
- Establish, implement, maintain and monitor the processes for e.g. Document
Management, Change Control, Deviation and CAPA Management
- Perform regular assessments of the compliance and effectiveness of the Quality
System requirements and report the results to the management
- Conduct internal audits
- lead audits or inspections
- Being responsible for the Quality Oversight of the GMP facility in Visp
- Review and approve GMP documentation
- be responsible for the electronical Quality Management System
- Ensures an effective information exchange/ flow to other departments or interfaces
- Advise and guide personnel in GMP topics or issues
- Perform GMP trainings on site
- Built and structure a Quality Assurance/Quality System Team
**Your Profile**:
- Academic or university degree in pharmacy, microbiology, biotechnology, life science
- At least 5 years relevant experience in a regulated pharmaceutical environment
- Knowledge of biopharmaceutical manufacturing
- An accreditation of a Qualified Person from the Swiss Health Authorities is a must
- Strong background in GMP is an asset
- Experience as a team lead is an advantage
- Structured, focused and well-organized working attitude
- Being agile, highly motivated and dynamic drive is needed in this fast-paced environment
- Motivated to move topics forward and bring it to an end and deliver the right quality
- Good skills in communication and connection between interfaces, within organizations and sites
- Knowledge in LEAN principles is an advantage
- Very good communication skills in English (verbal and written)
You will be based in Visp, Switzerland. Some travel can occur (e.g., to other Bacthera locations).
Are you interested to work for an innovative, dynamic, and future oriented start-up company?
Art der Stelle: Vollzeit
Arbeitszeiten:
- Montag bis Freitag
Leistungen:
- Berufliche Altersvorsorge
- Firmenanlässe
- Firmennatel
- Homeoffice
- Kostenlose Getränke
- Kostenloses oder Vergünstigtes Essen
- Mitarbeiterrabatt
- Subventionsbeitrag für die Nutzung des öffentlichen Verkehrs
Sonderzahlung:
- Bonuszahlung
