Beschreibung
- As a modern company, our client manages to constantly develop further and break new ground.
- Our client is a very successful company and a global player in a number of industries. Due to its flat hierarchies and lean structures, our client offers significant potential for further development.
QA Expert Manufacturing (m/f/d)
Reference: -en
Start: asap
Duration: 12 MM++
Main tasks:
- Perform batch release for aseptic manufactured drug product produced in internal and external DP sites
- Write, review and approve deliverables (e.g. procedures, SOPs, cleaning documents, gap assessments) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure GMP compliance
- Ensure control that the corresponding elements of the corporate Lonza GMP Quality Manual are appropriately implemented and followed in Sterile Production Stein and at external manufacturing sites
- Document Review and approval including documents in electronic systems like MES (e.g. master batch records, executed batch record)
- Advice line functions concerning product and process related topics.
- Approve change requests, deviation and CAPAs related to product and process
- Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE, etc.) Promote and enforce compliance to guidelines.
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans
Main qualifications
- Experience as a QA Manager Manufacturing
- Experience in GMP and SOP
- Experience in Trackwise
- German and English must have
- Teamplayer
Main advantages:
- A highly motivated team and an open way of communication
- A variety of cultural and recreational offers
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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