How you’ll spend your day
Preparation and review of batch documentation for re-certification batches in Israel by Qualified Person
Preparation of batch documentation files based on prioritization provided by Supply chain
Handling of Deviations and CAPA – creating deviation in computerized system and follow the progression of the investigation
Comply with KPIs for Batch release
Strive to maintain KPIs for batch release (timeframe for release), deviations and CAPAs
Handling of Temperature excursions registered
Working with a variety of internal and external collaboration partners:
– External: suppliers/manufacturers of imported products
– Internal: supply-chain, regulatory affairs, warehouse, marketing etc.
Focal point with Israel Ministry of Health regarding First batch release submission (Launch) and Packaging material up-date
Your experience and qualifications
Bachelor’s degree in Life Sciences or related discipline required
Experience in QA in pharmaceutical industry required (plant floor advantage)
B.A degree in Pharmaceutical Sciences – (B. Pharm) Advantage**
Work with computerized system: SAP, TrackWise and Veeva advantage
** Possible opportunity for QP qualification in the future.
