Job Description
<Job Responsibilities> 1. Set－Up Period - Preparation of ISO13485 documents - Preparation of Medical Device Establishment License documents - Preparation of Good Manufacturing Practice document - Halal documents other than the ISO13485 document（QMS） - Confirmation of Halal declarations from raw material manufacturers - Creating Halal-compliant working methods - Preparation of Halal-compliant work equipment - Storage and management of Halal-compliant raw materials - Manage Semi-finished products and finished products 2. Routine Work 2.1 Quality Assurance (QA) Tasks - Update ISO13485 documents - Update Medical Device Establishment License documents - Update Good Manufacturing Practice (GMP) documents - Check the Company QMS documents 2.2 Halal Certification Tasks - Selection of Halal Committee Members - Launch of Halal License Project - Implementation of Basic Halal Education - Halal Certification Activities - Update on New Rules for Halal Certification - Update on New Rules for Sales in Indonesia and Malaysia
Job Requirement
<Necessary Skill / Experience > - Diploma or Bachelor’s degree in Biotechnology, Pharmacy, Chemistry, or related fields. - At least 3 years of experience in Regulatory Affairs, QC, and QA in FMCG, Medical Device and Equipment, or Halal-Certified related products. - Conversational Middle Level in English (Communicate internally with Japanese, email, documents, and reports) - Able to prepare, update, and maintain regulatory and Halal documentation. - Strong understanding of ISO13485 and Good Manufacturing Practices (GMP) standards <In Details> - Detail-oriented with strong organizational and project management skills. - Ability to train and educate staff on Halal compliance and quality management systems. <Preferable Skill / Experience> - Experience in a Japanese Company - Experience in the establishment or management of Indonesian Halal. - Familiarity with export regulations and cross-border Halal certification processes - Experience in coordinating with government agencies such as the Ministry of Public Health (MOPH), Halal CICOT, BPJPH, and BPOM.