The PJT cum QA Engineer is the company’s technical authority responsible for ensuring that all household products (Perbekalan Kesehatan Rumah Tangga – PKRT) and cosmetics/personal care manufacturing activities comply with CPPKRTB, CPKB, and applicable regulations.
In addition to fulfilling the PJT’s regulatory obligations, the role includes developing and maintaining the quality management system, overseeing product quality, and supporting continuous improvement in production processes.
Key Responsibilities:
A. Penanggung Jawab Teknis (PJT) Responsibilities
- Develop, implement, and maintain Quality Management System, Halal Assurance System, GMP certification requirements - CPPKRTB, CPKB, and other relevant system and certification as required by the organization.
- Manage and ensure compliance the management systems and certifications requirements, and relevant national laws and regulations.
- Develop, implement, and maintain quality procedures and SOPs aligned with CPPKRTB, CPKB and quality management system.
- Coordinate and prepare for certification and surveillance audits, ensuring all documentation and processes are audit-ready.
- Liaise with external auditors, certification bodies, and regulatory authorities to maintain certifications and resolve any non-conformances.
- Stay updated on changes in regulatory and certification requirements, advising the organization on necessary adjustments.
- Managed and led audits across internal, certification body, customers, and regulatory domains, preparing detailed reports and driving issue resolution.
- Plan and conduct internal audits of management systems to identify areas for improvement.
- Monitor the effectiveness of corrective actions and ensure timely closure of audit findings.
- Maintain document management system to ensure compliance with organizational standards, ISO requirements, and regulatory frameworks.
- Plan, coordinate, and execute mock recall exercises to validate the effectiveness of traceability and recall systems.
- Manage and oversee product recalls or quality issues when needed.
- Coordinated management reviews, data collection, and reporting.
- Provide training and technical guidance to staffs on standard operating procedures (SOPs).
- Collaborate with relevant functions to perform risk assessments for products and processes.
- Supervise and verify manufacturing processes to ensure compliance with approved methods.
Qualifications
- Minimum Bachelor’s degree in Pharmacy, Chemistry, Chemical Engineering, or Industrial Engineering (must meet KEMENKES requirements for PJT appointment).
- Have a CPPKRTB training certificate for PJT PKRT.
- Minimum 1-2 years in manufacturing or quality assurance in household or cosmetics/ personal care product, pharmaceutical or food industries.
- Experience with regulatory compliance, CPKB, CPPKRTB, and product registration processes preferred.
- Strong attention to detail, documentation skills, and regulatory knowledge.
Skills:
- Strong understanding of CPPKRTB, CPKB, and quality management systems.
- Knowledge of applicable national regulations and standards
- Strong communication and leadership skills
- Analytical and problem-solving abilities
- Documentation and reporting skills
- Proficient in Microsoft Office and technical software tools
Job Type: Full-time
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