Computerized System Validation Specialist
Be'Er Sheva, Israel, 1
Who we are
TAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products, TAPI is the go-to global supplier for APIs, supporting 75% of the top 50 global pharmaceutical companies. Headquartered in Israel, TAPI employs more than 4,000 professionals at 13 sites worldwide. We provide superior product quality and excellent customer service.
Our employees are at the core of our success, Join us on our journey of growth!
How you’ll spend your day
- Responsibility for Global and Local Computerized system (Computerized system technical owner), adequacy, maintenance and validation activities. Compliance to CFR Part 11, annex 11.
- Provide quality support and guidance to operation, qualification, validation, monitoring and maintenance of Critical Systems as Purified water, HVAC systems, Process gases as Nitrogen, air etc.
- Environmental monitoring
- Data Integrity
- SOP's
- External and Internal audits
- API shipments monitoring
- Employees qualification and Training
- Handle supplier quality management, including supplier qualification and evaluation, Quality agreements and conducting supplier quality audit
Your experience and qualifications
- BSc. in life science/ engineering or similar field
- Experience in Computerized System and validation of computerized system following CFR Part 11 and Annex 11.
Reports To
Assoc Dir Quality Function
Already Working @TEVA?
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