Registration QA Compliance Supervisor
About this position
Quality assurance (QA) plays a critical role in ensuring that pharmaceutical products meet the required quality standards. In the pharmaceutical industry, a QA person is responsible for ensuring that products are manufactured, tested, and released according to the relevant regulations and guidelines.
Responsibilities
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advise on the submission strategy
• Timely compile materials for license renewals, updates and registrations
• Maintain regulatory files/database and chronologies in good order.
• Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Responsible for all steps of Research issues
• Responsible for preparation of Registration files for any new product.
• Responsible for creating Designs for New products.
• Responsible for Registration of Drugs, Cosmetics, Food Supplements & Medical devices in CAPA.
• Responsible for Registration of Special Nutrition in NIN.
• Responsible for following steps of formulations and stability study of any New products.
• Responsible for execution of Damaged and Expired products in Vacsera.
Requirements
• Apothecaries,
• with minimum 2 yr of experiences at related departments
• Deep knowledge of quality assurance terminology, methods, and tools.
• Working knowledge of tools, methods and concepts of quality assurance
• Solid knowledge of relevant regulatory standards
• Good communication skills, both verbal and written
• Excellent data collection and analysis skills
• Strong attention to detail
• Superb computer skills, including database management
• Willing to work from site Cikarang
Benefits
9,000,000 - 21,000,000 IDR per month
