The Head of QC, a member of the Quality Unit, is responsible to establish the Quality Control unit including all analytical capabilities needed to support the clinical and commercial manufacturing of LPBs. She/He must ensure that the analytical requirements are defined in compliance with emerging and established national/international requirements and GMP standards.
QC Site Head Visp (f/m/d) 100 %
- Builds the QC Labs (Microbiology and Physico-Chemical lab) including engineering part (required facilities, utilities, IT, etc…), required equipment, implementation of processes, implementation of Environmental Control strategy, implementation of required software’s, according to GMP guidelines
- Leads, coaches and develops a team of highly skilled specialists/analysts, with the right flexibility and competences, able to handle multiple products/ analysis, in close interaction with Bacthera’s customers and the rest of the organization.
- Ensures that priorities are set and timelines are respected as required by customer, authorities or internal constraints.
- Establishes and reviews documents, procedures, methods and specifications that impact identification, strength, quality, and purity of Raw & Packaging materials, drug substances and drug products
- Responsible for raw material and packaging management relevant to sampling, testing and release to production
- Has the oversight of analytical testing conducted as in-process control and all analytical activities delegated to production.
- Handles retain and reference samples stock according to local procedures and customer requirements
- Responsible for environmental monitoring program by reviewing and assessing the results and yearly trend reports
- Ensure the implementation of new methods and equipment/instrumentation by performing required testing in support of development, transfer and validations,
Implements lab equipment’s and ensures that QC lab equipment is properly qualified and maintained according to company’s internal requirements
- Ensure that out-of-specification analyses, deviations, and quality complaints related to analytics are investigated and documented; assist in determining appropriate CAPA; and communicate with internal and external stakeholders
- Assist to regulatory inspections and client audits as well as audits to external labs or as required
- Maintain current knowledge of applicable regulations, guidance and standard via a properly established surveillance system.
- Acts as owner of company’s lab/sample management electronic system (LIMS)
- Set the Quality Control strategy and direction in alignment with company’s objectives
- Implements the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement
- Bachelor degree, Master degree in biotechnology, pharmacy, life science or related field.
- More than 5years of experience in the GMP regulated pharmaceutical industry, preferably in a quality and compliance role in production and CAPEX projects.
- Strong background GMP regulations.
- Strong team orientation.
- Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive.
- General knowledge of manufacturing processes and analytical methods.
- Ability to oversee project execution to identify non-compliance from quality standards.
- Ability to prioritize and manage work to critical project timelines in a fast-paced environment.
- A good operational level of both English and German
- Innovative and fast growing start-up company with short decision-making processes
- Flexible working hours (possibility of Home Office)
- Motivated, agile and multinational team
- Very good pension fund and attractive salary
- Fringe benefits (e.g. Lunch card, deduction at different stores, Job ticket for public transport)
- Interesting and diversified tasks
This is the opportunity to be part of a fast growing start-up company, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting to you, we are looking forward to hear more about you. Only direct applications are considered.
Frau Sandra Gamboni
Global Head of Human Resources
+41 78 661 51 73