Senior Manager QA Compliance & Systems Sisslerfeld (a), 100% — Bachem AG
NewCHF 99'500 - 169'500
Bachem AG · Stein AG (AG)
- Location
- Stein AG
- Contract
- full-time
- Posted
- Yesterday
SalaryCHF 99'500 - 169'500
Role overview
The Bachem Group is investing in a new location in Sisslerfeld in northwestern Switzerland.
This step is part of the long-term strategy to expand production capacity by the end of the decade.
The new production site will play a central role in achieving these goals.
- The Bachem Group is investing in a new location in Sisslerfeld in northwestern Switzerland.
- This step is part of the long-term strategy to expand production capacity by the end of the decade.
Contacts
- and interaction with Swissmedic, Regional Therapeutic Products Institute and other relevant authorities (e.g.
- Submission of change reports, planning of authority inspections, etc.)
- Planning, coordination and execution of mock audits and self-inspections as preparation for achieving the "site license" and for checking compliance with quality standards
- Presentation of the department's QM processes during customer audits and authority inspections
- Responsible for the implementation of the implementation of training courses for employees in relation to quality management and regulatory requirements
- Collaboration and support of global quality management projects in the Quality Systems and Compliance Department
Company and context
- The design phase of the project offers you unique opportunities to help shape the future organization.
- To strengthen our team in the Global Quality Department Sisslerfeld, we are looking for a dedicated Senior Manager QA Compliance & Systems (a), 100%. Your tasks:
- Planning, setting up, leading and further developing the Quality Systems and Compliance organizational unit at the Sisslerfeld site
- Monitoring the changing pharmaceutical legislation and its internal implementation at Bachem
- Supporting the coordination of the activities of internal and external parties to ensure the timely achievement of project milestones
- Setting up and implementing the quality management systems and processes and their continuous improvement
- Definition of quality-relevant key figures as well as planning and carrying out the quality management review with the active involvement of the site management
- Ensuring compliance with regulatory requirements, such as Good Manufacturing Practice (GMP)
- Creation, review and approval of site master files, policies & SOPs etc. in the department as well as coordination with global processes
- Collaborate with stakeholders at all levels of the organization to ensure coordination and support of improvement initiatives
Additional details
- To strengthen our team in the Global Quality Department Sisslerfeld, we are looking for a dedicated Senior Manager QA Compliance & Systems (a), 100%.
- Contact and interaction with Swissmedic, Regional Therapeutic Products Institute and other relevant authorities (e.g.
- Taking on other/additional tasks as instructed Responsible for the E
Notes and original content
- Your tasks:
- Taking on other/additional tasks as instructed
- Responsible for the E
