Quality Assurance Halal Supervisor (Apoteker)

Quality Assurance Halal Supervisor (Apoteker)

Oversee and ensure the registration of halal products according to Indonesian regulations.

Prepare and manage Special Access Scheme (SAS) documentation for imported products, active substances, and innovator products to ensure compliance with national standards.

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. This responsibility would also ensure no equipment is overdue for calibration, thereby maintaining compliance.
6. Deviation and CAPA Management
   Deviation Management: The QA Halal Supervisor could handle any deviations or non-conformities in the halal certification process. They would investigate, evaluate, and follow up on any deviations related to qualification or registration issues, ensuring that halal standards are met.
   Corrective and Preventive Actions (CAPA): To enhance quality assurance, the role could include monitoring and addressing CAPA recommendations from events or deviations. This would ensure any corrective actions related to halal processes are completed on time and in compliance with halal guidelines.
7. Procedure Review and Compliance Updates
   Procedure Review and Creation: Adding responsibilities for creating or updating SOPs and templates specifically related to halal certification and lifecycle management would ensure procedures are always aligned with the latest halal and regulatory requirements.
   Compliance with Cross-Functional SOPs: Ensuring that SOPs, especially for procedures intersecting halal and other regulatory aspects (e.g., CPOB, HALAL, SMK3) are in compliance, could strengthen the role’s alignment with broader quality systems.
8. Proxy Duties
   The QA Halal Supervisor could 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
   To align with Bayer’s focus on occupational safety, the QA Halal Supervisor could support maintaining health, safety, and facility security within the halal operations area, ensuring halal processes are also aligned with company safety standards.

Requirements

1. Educational Background
   Bachelor’s Degree in Pharmacy and advanced degree with certification in Quality Assurance and Halal Studies.
2. Experience
   Minimum 3-5 years in Quality Assurance or Regulatory Affairs, ideally within the pharmaceutical with direct experience in halal product certification.
   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 (e.g., Qualification Plans, Protocols, and Reports) as well as 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.