Description
Senior QA Specialist - NOVJP (m/f)
Reference: -en
Start: asap
Duration: 3 MM++
Main tasks:
- Coordination of the handling and decision of “critical” and “non-critical” microbiological deviations including approval of the respective microbiological risk assessment of batches involved
- Definition and tracking of CAPAs for preventing recurrence of deviations
- Support of production in the (re-)qualification of clean room personnel and operator trainings
- Supervision and periodic checks of the aseptic working technique during Media Fills or on surprise (VIMOS)
- Assurance and optimization of validation of aseptic processes by Media Fills in time
- Perform trend analyses/reports (incl. findings) of the environmental monitoring on a routine basis
- Evaluation of relevant product, process and facility related microbiological aspects (BET, sterility and BB tests) as well as the findings of environmental monitoring, water analyses and Media Fills
- Support, preparation and participation of authority or customer inspections and registration as a biological/microbiological expert
- Cooperation with registration department and authority reviewers in order to optimize the quality of the (re-)registration documents
- Creation, update and approval of SOPs, statements and risk assessments
Main qualifications
- Degree in general or medical microbiology, biochemistry, pharmacy or equivalent
- Profound experience in biological/microbiological analytics or diagnostics including aseptic working techniques
- Good experience in quality control/assurance in pharmaceutical industry or biotechnology, especially with regard to sterile products
- Experience in manufacturing of sterile drug products and aseptic filling
- Fluent German and English (spoken/written)
Main advantages:
- A very renowned company
- Interesting tasks in a multinational environment
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.
My contact at Hays:
My contact person:
Svenja Weiß
Referencenumber:
Make contact:
Email: