Teva Senior Specialist Commercial Quality 

Indonesia, Special Capital Region of Jakarta 

491489060

We are looking someone :

• To ensure operational implementation of Quality Management System and Governance in compliance with GMP&GDP, Teva Corporate Standards and all regulatory requirements (marketing authorizations)
• Responsible for quality oversight and regulatory compliance of products marketed in the Indonesia (ID) markets, including process assurance and operational support
• Responsible for quality oversight and management of local 3rd party (i.e. distributors, suppliers/manufacturers)

• S1, Bachelor Degree in Pharmacy and/or Professional Degree (Apothecary)
• 3-5 years’ experience in the same field in multinational/local pharmaceutical company
• Computer literacy and English is a must (Written and spoken)
• cGMP, GDP, Indonesian/Local Regulation
• Analytical skill
• Good communication and interpersonal skill, stakeholders management skill

• Handling of new and existing imported finished products, including vendor/supplier qualification, periodic vendor audit, reviewing vendor documents for disposition of imported products, quality risk management, etc.), QTA, shipment temperature assessment
• Handling of new and existing finished products CMO (i.e. vendor/CMO qualification, periodic CMO audit, QTA, reviewing CMO documents for disposition of CMO products, quality risk management, etc.)
• Handling of license for import cosmetic products or others products categories and distribution from BPOM (i.e. Indonesian pharmacist license is required and registered in BPOM on behalf of the company to apply for cosmetic products import license; receiving audit from BPOM; create CAPA plan, follow up and monitor completion of CAPAs; maintain license renewal after receiving to avoid exit validity, etc.), QTA, shipment temperature assessment
• Handling of new and existing distributors, including distributor qualification, periodic routine audit, in-market distribution oversight, QTA
• Handling of product disposition of imported finished products and finished products coming from CMO for local markets
• Responsible for resolving of product non-conformity in a timely manner with appropriate partners, including preparing QRM if necessary, monitoring of CAPA
• Handling product complaint for local market, that coming from third parties in coordination with related department/ manufacturing and/or release site in order to cope with comply complaints in timely manner, including handling of counterfeit & tampering products
• Handling product recall for local market in coordination with recall community in order to comply with current GMP, TEVA Corporate Standards and regulatory requirements
• Responsible for ensuring returned product disposition (returned goods assessment) complies with established procedures or agreements, including quality management and approval of rework (repacking/redressing/ relabeling) for imported products/products coming from CMO or special inspection operations performed
• Support change management system for PT Actavis Indonesia related to local market products in order to comply with current GMP, GDP, TEVA Corporate Standards and Regulatory requirements
• Prepare product samples (not for sale) for marketing program, if required
• Support QTA (Quality Technical Agreement) drafting and finalization for PT Actavis Indonesia related to local market products in order to comply with current GMP, GDP, TEVA Corporate Standards and Regulatory requirements
• Perform quality audits on local distributors, CMO, contractors periodically
• Perform internal self-inspection, monitoring and quality oversight on local distributors, CMO, contractors periodically
• Prepare and maintain all documentation related to incumbent areas of responsibility in order with current GMP, GDP, TEVA Corporate Standards and Regulatory requirements
• Prepare and develop all Standard Operating Procedure in order to comply with current GMP, GDP, TEVA Corporate Standards and regulatory requirements
• Prepare and manage Quality Council and Management review periodically

Associate Director Commercial Quality, ASEAN & S.Korea

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