Deskripsi Pekerjaan
Multi Indomandiri is seeking a detail-oriented and analytical Validation Staff to join our dynamic team in Karawang. In this role, you will be a critical part of our quality assurance and compliance department, ensuring that all processes, equipment, and analytical methods adhere to the highest industry standards for the pharmaceutical, chemical, and household health products (PKRT) sectors.
As a Validation Staff, you will bridge the gap between technical operations and regulatory compliance, maintaining rigorous documentation and executing validation protocols that guarantee product safety and efficacy. If you are passionate about precision, data integrity, and continuous improvement in a manufacturing environment, we invite you to apply.
Tanggung Jawab
- Develop, execute, and document validation protocols (IQ/OQ/PQ) for production equipment and utility systems.
- Conduct validation of analytical methods to ensure accuracy and reproducibility in laboratory testing.
- Monitor and troubleshoot process variations to maintain compliance with CPOB/GMP standards.
- Perform periodic reviews of validation status for existing processes and equipment.
- Collaborate with the Quality Assurance team to perform risk assessments and root cause analysis (RCA).
- Maintain comprehensive documentation and prepare detailed validation reports for internal and external audits.
- Support the implementation of new technologies or process changes through robust validation planning.
Kualifikasi
- Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related science discipline.
- Minimum 1-2 years of experience in Validation or Quality Assurance within the pharmaceutical, chemical, or PKRT industry.
- In-depth understanding of GMP (Good Manufacturing Practices) and CPOB regulations.
- Proficient in technical writing and data analysis.
- Strong analytical mindset with keen attention to detail and ability to work with complex data sets.
- Ability to work effectively in a cross-functional team environment.
- Proficiency in Microsoft Office Suite (Word, Excel) for report generation.