משרות תוצאות חיפוש מתאימות לבקשתך:

The opportunity
Assist to coordinate GMP aspects in manufacturing area according to European and local GMP regulation, EHS policy and Corporate policy that all activities in accordance with cGMP, EHS policy and Corporate policy
Assist for managing quality system and compliance within the site to ensure the compliances of the current GMP and corporate policy

How you’ll spend your day
Prepare Product Quality Review (PQR) based on schedule according to current GMP, MA requirements, and corporate policy. Monitor and follow-up for the completion of all PQR according to defined schedule
Responsible for vendor qualification activities
Perform coordination in Quality documents collection and updating required documents for material
Perform coordination of self-inspection and vendor audit program according to defined schedule
Create Quality Project and CAPA related to internal Audit results, QRM, and PQR
Assist to prepare and control documentation of Quality Technical Agreement (QTA). Maintain the valid QTA
Manage change control of equipment, facility, and utility and packaging material
Prepare Nitrosamine Risk Assessment for related products according to predefined schedule and support to coordinate the sample shipment for confirmatory testing purpose
Review packaging validation, qualification and computer system validation documents
Part of Halal Management Team
Ensure that medicinal products are distributed in accordance with GDP standard