Senior Specialist, Commercial Quality
Teva Pharmaeutical (Indonesia)
Indonesia | DKI Jakarta
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Last updated 3 days ago
Teva Pharmaeutical (Indonesia)
Indonesia | DKI Jakarta
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Last updated 3 days ago
Grab
Indonesia | DKI Jakarta
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Flex
Indonesia | Riau
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Last updated 2 weeks ago
Flex
Indonesia | Riau
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Flex
Indonesia | Riau
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PT Arisamandiri Pratama
Indonesia | Central Java
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Last updated 1 month ago
PT Hongfa Electronic Indonesia
Indonesia | Banten
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PT Mattel Indonesia
Indonesia | West Java
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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.
โข To ensure operational implementation of Quality Management System and Governance in compliance with GMP&GDP, Teva Corporate Standards and all regulatory requirements (marketing authorizations)
โข Responsible for quality oversight and regulatory compliance of products marketed in the Indonesia (ID) markets, including process assurance and operational support
โข Responsible for quality oversight and management of local 3rd party (i.e. distributors, suppliers/manufacturers)
โข 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
โข 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.)
โข 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
โข Handling of new and existing distributors, including distributor qualification, periodic routine audit, in-market distribution oversight, QTA
โข Handling of product disposition of imported finished products and finished products coming from CMO for local markets
โข Responsible for resolving of product non-conformity in a timely manner with appropriate partners, including preparing QRM if necessary, monitoring of CAPA
โข 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
โข S1, Bachelor Degree in Pharmacy and/or Professional Degree (Apothecary)
โข 3-5 yearsโ experience in the same field in multinational/local pharmaceutical company
โข Computer literacy and English is a must (Written and spoken)
โข cGMP, GDP, Indonesian/Local Regulation
โข Analytical skill
โข Good communication and interpersonal skill, stakeholders management skill