QA Halal Supervisor

Amarox Pharma Global
Garut
IDR 100,000,000 - 200,000,000
Job description

Quality Assurance & Control (Manufacturing, Transport & Logistics)

Full time

Key Responsibilities

  1. Understanding and Compliance with Halal Regulations
    • Maintain up-to-date knowledge of Indonesia’s halal regulations, including those from BPJPH (Badan Penyelenggara Jaminan Produk Halal), MUI (Majelis Ulama Indonesia), and other relevant bodies.
    • Ensure that all processes related to halal certification are in full compliance with current regulatory standards.
  2. Halal Product Registration
    • Coordinate with relevant departments to prepare all necessary documents for halal registration, including technical specifications, ingredient lists, supplier certifications, and other required information.
    • Oversee the halal registration process from initial submission to certification, including responding to any inquiries or additional information requests from regulatory bodies.
    • Keep a record of all registered halal products and maintain periodic renewals and updates as required by law.
  3. Development and Implementation of Halal Registration Procedures
    • Develop, document, and update standard operating procedures (SOPs) related to the halal registration process.
    • Provide training and guidance to team members and other departments on halal procedures to ensure adherence to established protocols.
    • Conduct regular reviews and updates of SOPs to reflect any changes in regulations or company policies.
  4. Preparation of SAS Documentation for Imported Products, Active Substances, and Innovator Products
    • Prepare SAS applications, including the collation and submission of all necessary data and documents for products that fall under the special access scheme.
    • Coordinate with import, regulatory, and quality teams to ensure that SAS documentation meets all regulatory requirements and timelines.
    • Follow up on the status of SAS submissions, address any additional requirements or feedback from regulatory authorities, and maintain records of all SAS-approved items.
  5. Documentation and Qualification Activities
    • Document Preparation for Qualification: Add responsibilities related to preparing qualification documentation for halal certification activities, such as Qualification Plans, Protocols, and Reports, ensuring they align with SOPs and halal guidelines.
    • Process Verification and Calibration: Implementing regular checks to confirm all equipment and technical systems related to halal production are maintained and calibrated.
  6. Deviation and CAPA Management
    • Deviation Management: Handle any deviations or non-conformities in the halal certification process, investigating and evaluating them to ensure halal standards are met.
    • Corrective and Preventive Actions (CAPA): Monitor and address CAPA recommendations from events or deviations to ensure corrective actions related to halal processes are completed on time.
  7. Procedure Review and Compliance Updates
    • Procedure Review and Creation: Create or update SOPs and templates related to halal certification and lifecycle management.
    • Compliance with Cross-Functional SOPs: Ensure compliance of SOPs intersecting halal and other regulatory aspects (e.g., CPOB, HALAL, SMK3).
  8. Proxy Duties
    • Act as a proxy for a senior quality role in the absence of the QA Manager, supporting quality oversight and continuity of halal certification processes.
  9. Occupational Safety and Health Compliance
    • Support maintaining health, safety, and facility security within the halal operations area, ensuring alignment with company safety standards.

Requirements

  1. Educational Background
    • Bachelor’s Degree in Pharmacy and advanced degree or certification in Quality Assurance, Halal Studies, or Regulatory Affairs is preferred.
  2. Experience
    • Minimum 3-5 years in Quality Assurance or Regulatory Affairs, ideally within the pharmaceutical or food industry, with direct experience in halal product certification.
    • Experience with technical systems lifecycle management as it applies to production and quality control processes.
    • Hands-on experience with CAPA processes and deviation management is preferred.
  3. Technical Skills
    • Halal Regulatory Knowledge: Strong understanding of halal regulatory requirements in Indonesia (BPJPH) and international halal standards.
    • SOP and Documentation Management: Proficient in preparing, evaluating, and maintaining qualification documentation and halal registration documents.
    • Compliance Expertise: Familiar with Good Manufacturing Practices (GMP), CPOB, and other quality standards relevant to halal certification.
    • Deviation and CAPA Management: Ability to assess deviations, initiate investigations, and lead corrective actions to align processes with halal compliance.
  4. Soft Skills
    • Attention to Detail: High level of precision in monitoring compliance, conducting audits, and documenting processes.
    • Project Management: Strong organizational skills to manage and oversee multiple halal certification processes, documentation, and audits.
    • Cross-Functional Collaboration: Skilled in working with departments such as Quality, Engineering, Supply Chain, and Production to ensure compliance in halal product processing.
    • Communication and Training: Capable of educating and training relevant personnel on halal compliance processes, regulatory updates, and quality procedures.
  5. Additional Requirements
    • Fluent in Bahasa Indonesia and proficient in English for documentation and regulatory correspondence.
    • Ability to work as a proxy in the absence of QA Manager, ensuring continuity in halal quality processes.
    • Knowledge of occupational safety and health standards in the production environment is an advantage.
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