Senior Specialist, Commercial Quality

Teva Pharmaeutical (Indonesia) (Gambir, Jakarta, Indonesia)

DKI Jakarta, Indonesia

Teva Pharmaceuticals has been developing and producing medicines to help improve people’s lives for more than a century. We are committed to being a global leader in generic and specialty medicines with a portfolio of 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day. They are served by one of the largest and most complex supply chains in the pharmaceutical industry. Along with our established presence in generics, we have significant innovative research and operations supporting our growing portfolio of specialty and biopharmaceutical products.

About this position

We are on a mission to make good health more affordable and accessible, helping millions enjoy healthier lives. This position involves ensuring quality management and regulatory compliance for products in the Indonesia market.

Responsibilities

• 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)
• 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 coun

Requirements

• 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