Teva QS & Compliance Officer 

Indonesia, Special Capital Region of Jakarta 

834214020

• 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

• 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

• Graduated Apothecary Program
• Fresh graduates are welcome to apply
• Reporting and interpersonal skills
• Computer Literacy & English Proficiency

QS & Compliance QA Manager

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