Chemist/QSD Analyst

Kimiki Solutions Inc.; Silang; On-site; PHP 300,000 - 540,000; Full time

Job summary

Quality Systems Management in the Philippines seeks a professional to develop and maintain laboratory quality systems, SOPs, and procedures in line with GMP, GLP and regulatory standards. You will monitor processes, conduct audits, and drive continual improvement across the lab.

Key duties include data analysis of lab and product testing results, preparing technical reports, supporting regulatory inspections, CAPA activities, documentation, and cross-department collaboration to ensure product

Responsibilities

• Develop and maintain laboratory quality systems, SOPs, and procedures in compliance with GMP, GLP, and regulatory requirements.
• Monitor laboratory processes and conduct quality audits to ensure compliance.
• Analyze laboratory and product testing data to assess quality and compliance with specifications.
• Prepare technical reports and assist in root cause analysis and CAPA for quality issues.
• Assist in the validation, verification, and qualification of analytical methods.
• Ensure proper documentation and compliance with regulatory standards.
• Ensure laboratory activities comply with applicable FDA, EMA, ISO, and other regulatory requirements.
• Support regulatory inspections, audits, and quality-related investigations.
• Collaborate with other departments to address quality and product integrity concerns.
• Identify and implement improvements in laboratory processes, efficiency, and quality systems.
• Train laboratory staff on quality procedures and best practices.
• Develop, improve, and reformulate products based on research, customer needs, and industry trends.
• Conduct R&D activities to support product innovation, troubleshooting, and optimization.

Job description

Quality Systems Management

• Develop and maintain laboratory quality systems, SOPs, and procedures in compliance with GMP, GLP, and regulatory requirements.

• Monitor laboratory processes and conduct quality audits to ensure compliance.

Data Analysis & Reporting

• Analyze laboratory and product testing data to assess quality and compliance with specifications.

• Prepare technical reports and assist in root cause analysis and CAPA for quality issues.

Method Validation & Qualification

• Assist in the validation, verification, and qualification of analytical methods.

• Ensure proper documentation and compliance with regulatory standards.

Regulatory & Compliance Support

• Ensure laboratory activities comply with applicable FDA, EMA, ISO, and other regulatory requirements.

• Support regulatory inspections, audits, and quality-related investigations.

• Collaborate with other departments to address quality and product integrity concerns.

Continuous Improvement & R&D

• Identify and implement improvements in laboratory processes, efficiency, and quality systems.

• Train laboratory staff on quality procedures and best practices.

• Develop, improve, and reformulate products based on research, customer needs, and industry trends.

• Conduct R&D activities to support product innovation, troubleshooting, and optimization.