Beschreibung
AS&T QC Expert for CMOs (m/f/d)
Reference: -en
Start: asap
Duration: 20 MM++
Main tasks:
- Write equivalence reports for the customer and CMO testing monographs
- Responsible for writing and coordinating Agile Change Requests AQWA (track wise) actions/deviations/quality events
- Ensure that coordinated contact is maintained with other functions within the company also dealing with external suppliers namely Purchasing, Legal, Supply Chain, Regulatory CMC, Drug RegulatoryAffairs, Group Quality Operations
- Support Launch and transfer Project QAMs regarding interpretation and review of analytical data/reports
- Participates and/or prepares cGMP audits of external contract laboratories and supplier/CMO laboratories, as required
Main qualifications
- Bachelor or higher degree in Biochemistry, Chemistry, Microbiology or other related science
- Working experience in Pharma (API): profound experience with strong analytical background (Testing methods for API analytics) - With very strong experience in API and analytics
- Proficient experiences in managing and executing AS&T activities preferable in product and method transfers
- Strategic thinking and sound knowledge of GMP guidelines (EU, US, ROW)
- High learning agility and knowing of executing tasks in IT tools like Trackwise (AQWA), Subway, Agile desirable
Main advantages:
- We will create a candidate profile containing your strengths and potential and thus increase your chance of being placed in a position
- A very renowned company
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:
Mihai-Lucian Burcea
Referencenumber:
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