Responsibilities

• 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.

Qualifications:

• Education: Bachelor’s Degree in Chemistry or a related science/technical discipline.
• Licensure: Must possess a valid Registered Chemist license or Registered Chemical Engineer license
• Experience: 1-3 years experience in data analysis, quality systems, or a related field, preferably in a regulated industry.

Skills:

• Strong analytical and problem-solving abilities.
• Excellent organizational and time management skills.
• Strong communication (written and verbal) and interpersonal skills.
• Ability to manage multiple priorities and meet deadlines.