job description
Multi Indomandiri is seeking a detail-oriented and highly analytical Validation Staff to join our expanding team in Karawang. As a key member of our quality and production department, you will play a vital role in ensuring that our manufacturing processes, equipment, and analytical methods consistently meet the stringent regulatory standards of the pharmaceutical, chemical, and PKRT industries.
In this role, you will be responsible for designing and executing validation protocols, analyzing technical data, and preparing comprehensive reports that ensure operational excellence. We are looking for a professional who thrives in a fast-paced environment and is committed to maintaining the highest levels of safety and quality assurance. If you are passionate about process improvement and have a solid foundation in industrial validation, we invite you to grow your career with us.
Responsibility
- Plan, execute, and document validation activities for manufacturing processes, equipment, and utility systems.
- Develop and implement robust validation protocols (IQ/OQ/PQ) in accordance with CPOB/GMP guidelines.
- Perform analytical method validation to ensure the accuracy and reliability of laboratory testing procedures.
- Analyze technical data and prepare summary reports for internal and external audits.
- Collaborate with cross-functional teams, including Production, Quality Assurance, and Engineering, to resolve deviations or non-conformances.
- Monitor and ensure all processes remain in a state of control throughout the product lifecycle.
- Participate in risk assessment activities (FMEA) to identify and mitigate process-related issues.
Qualifications
- Bachelor’s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field.
- Minimum 1-2 years of experience in validation, quality assurance, or quality control within the pharmaceutical or chemical industry.
- In-depth understanding of GMP (CPOB), GLP, and ISO standards relevant to the PKRT/Pharmaceutical industry.
- Proficiency in statistical analysis and technical writing for regulatory documentation.
- Strong problem-solving skills with a high degree of attention to detail and accuracy.
- Ability to work effectively in a team environment and handle multiple projects simultaneously.
- Fresh graduates with excellent academic records and internship experience in validation are encouraged to apply.