
Pharmaceutical Quality Expert
1 week ago
**Job Overview**
As a Senior Quality Specialist, you will be responsible for ensuring timely and compliant reviews of CMC documentation according to industry standards.- Reviewing Method Development, Validation Protocols, Reports, Stability Protocols, Reports from various sites, R D units, and Testing Centres.
- Reviewing Instrument Equipment Qualification records.
- Reviewing Business Management Reviews.
**Key Responsibilities:**
- Compiling high-quality Annual Product Reviews (APRs) and Product Quality Reviews (PQRs).
- Liaising with third-party contract manufacturers and QA/QC Technical support personnel globally for data collection and arranging responses.
- Recommending actions and professionally communicating with sites and Quality units for continuous improvement in product quality.
- Escalating issues to Supervisor, Group Leader, Manager Global Quality GBS, and contemporaneously updating the SharePoint database.
**Requirements:**
- 3-5 years of experience in QA, QC functions in the pharmaceutical industry.
- Master's Degree in Pharmacy or other natural sciences or Bachelor Degree in Pharmacy or other natural sciences or MSc in Chemistry.
- Basic knowledge on worldwide cGxP regulations.
- Good English language skills, and other language skills could be helpful.
- Basic knowledge of Computerised Systems and Knowledge of Systems in TEVA's IT landscape.
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