How you’ll spend your day
Ensures that the review of CMC documentation is completed in timely & compliant manner as per Teva CORP standards and related Guidance’s.
Review of Method Development/Validation Protocols & Reports, Stability Protocols & Reports received from various Teva contracting sites, R&D units, Method Development & Stability Testing Centres.
Review of BMR.
Review of Instrument, Equipment Qualification/Calibration/maintenance
Review of CSV documents
Release of Materials
Liaising with R&D Quality personnel located globally for data collection and arranging responses.
Recommend actions and professionally communicate to R&D sites/ Quality units for continuous improvement in quality of products
Receives guidance from Manager, Head GBS Quality and R&D Quality
Your experience and qualifications
5 to 10 years of experience in QA / QC function in the pharmaceutical industry
Master’s Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences
Basic knowledge on worldwide cGxP regulations
Good English language skills, other language skills could be helpful
Good communication skills
Basic knowledge of Computerised Systems. Knowledge of Systems in TEVA´s IT landscape (TrackWise, SAP, LIMS, Global Insights, Glorya etc.) would be of advantage
Basic understanding R&D processes
Engagement to drive improvements and ability to manage complexity
