[ROLES & RESPONSIBILITIES]
1. Maintain GxP compliance
- Keep abreast of the requirements and the latest trends in GxP and attend suitable training to meet those needs.
- Provide training to QC employees on GxP and monitor of training plan, result and effectiveness.
- Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations.
2. Quality Control Management Roles
1. Validation Activities:
• Plan, coordinate, and execute validation activities, including method validation, lab equipment qualification, and software validation, in compliance with regulatory requirements.
• Develop and implement validation/qualification protocols and reports.
2. Regulatory Compliance:
• Stay up-to-date with relevant regulations (e.g., MFDS) and ensure laboratory compliance.
• Assist in preparing for and participating in regulatory audits and inspections.
• Enhance the accuracy and reliability of test results through data integrity compliance.
3. Documentation and Record-keeping:
• Establish and maintain comprehensive documentation for all validation activities.
• Ensure documentation is accurate, organized, and easily accessible.
4. Lab Support:
• Provide support to laboratory operations by troubleshooting issues, optimizing processes, and ensuring efficient workflow.
• Collaborate with laboratory personnel to address quality and technical concerns.
5. Training and Development:
• Train and mentor laboratory staff involved in validation activities.
• Promote a culture of continuous learning and skill development.
6. Change Control:
• Oversee the change control process and evaluate the impact of changes on validated processes.
• Ensure changes are implemented following established protocols.
7. Reporting and Communication:
• Maintain clear and timely communication with relevant stakeholders.
8. Audit and Inspection Preparedness:
• Ensure the laboratory is prepared for regulatory audits and inspections.
• Address any findings and implement corrective and preventive actions as needed.
9. Safety and Compliance:
• Promote a culture of safety in the laboratory.
• Ensure that safety protocols and ethical standards are followed at all times.
[QUALIFICATIONS]
1. University degree or equivalent in Chemistry, Biology, Biotechnology or equivalent.
2. Minimum of 10 years professional experience is required (in pharmaceutical industry/QC) in a GMP regulated environment for the production of pharmaceuticals or biopharmaceuticals.
3. A good background in analytical methods (HPLC, GC, UV, IR). Expertise in MV, PV, CV, and Stability study. An excellent knowledge of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical methods and validations.
4. Good computer skills.
5. Good command of Korean and English
[ROLES & RESPONSIBILITIES]
1. Maintain GxP compliance
- Keep abreast of the requirements and the latest trends in GxP and attend suitable training to meet those needs.
- Provide training to QC employees on GxP and monitor of training plan, result and effectiveness.
- Preparation of programs for corrective and preventative actions (CAPA) after inspections conducted by regulatory bodies, customers, and other external organizations.
2. Quality Control Management Roles
1. Validation Activities:
• Plan, coordinate, and execute validation activities, including method validation, lab equipment qualification, and software validation, in compliance with regulatory requirements.
• Develop and implement validation/qualification protocols and reports.
2. Regulatory Compliance:
• Stay up-to-date with relevant regulations (e.g., MFDS) and ensure laboratory compliance.
• Assist in preparing for and participating in regulatory audits and inspections.
• Enhance the accuracy and reliability of test results through data integrity compliance.
3. Documentation and Record-keeping:
• Establish and maintain comprehensive documentation for all validation activities.
• Ensure documentation is accurate, organized, and easily accessible.
4. Lab Support:
• Provide support to laboratory operations by troubleshooting issues, optimizing processes, and ensuring efficient workflow.
• Collaborate with laboratory personnel to address quality and technical concerns.
5. Training and Development:
• Train and mentor laboratory staff involved in validation activities.
• Promote a culture of continuous learning and skill development.
6. Change Control:
• Oversee the change control process and evaluate the impact of changes on validated processes.
• Ensure changes are implemented following established protocols.
7. Reporting and Communication:
• Maintain clear and timely communication with relevant stakeholders.
8. Audit and Inspection Preparedness:
• Ensure the laboratory is prepared for regulatory audits and inspections.
• Address any findings and implement corrective and preventive actions as needed.
9. Safety and Compliance:
• Promote a culture of safety in the laboratory.
• Ensure that safety protocols and ethical standards are followed at all times.
[QUALIFICATIONS]
1. University degree or equivalent in Chemistry, Biology, Biotechnology or equivalent.
2. Minimum of 10 years professional experience is required (in pharmaceutical industry/QC) in a GMP regulated environment for the production of pharmaceuticals or biopharmaceuticals.
3. A good background in analytical methods (HPLC, GC, UV, IR). Expertise in MV, PV, CV, and Stability study. An excellent knowledge of GMP, ICH, USP and global compendia regulations and guidance's, particularly as related to analytical methods and validations.
4. Good computer skills.
5. Good command of Korean and English