Job Description
Job Summary
- The QC Analyst will be responsible for performing routine and non-routine analysis of raw materials, in-process samples, finished products, and stability samples.
- This role ensures that all products meet the established standards of quality, purity, and efficacy.
Key Responsibilities
Sample Analysis:
- Conduct chemical and physical analysis of raw materials, in-process samples, finished products, and stability samples using techniques such as HPLC, GC, UV-Vis, FTIR, and titration.
- Perform microbiological testing where applicable.
Documentation:
- Maintain accurate and detailed records of all analytical results.
- Ensure proper documentation of all test results in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Prepare and review standard operating procedures (SOPs) and test methods.
Equipment Maintenance:
- Calibrate, validate, and maintain laboratory equipment to ensure proper functioning.
- Troubleshoot and resolve issues with laboratory instruments.
Compliance:
- Adhere to all safety, health, and environmental regulations.
- Ensure compliance with internal and external quality standards, including FDA, WHO, and other regulatory requirements.
- Participate in internal and external audits.
Continuous Improvement:
- Identify areas for process improvement within the QC laboratory.
- Implement and document changes to enhance quality control processes.
Team Collaboration:
- Work closely with production, quality assurance, and research and development teams to ensure product quality.
- Provide technical support and training to other laboratory staff.
Reporting:
- Prepare and present analytical reports and data summaries to management.
- Communicate any deviations or non-conformances observed during analysis.
Qualifications
- Education: Bachelor’s Degree in Chemistry, Biochemistry, Pharmacy, or a related field.
- Experience: At least 2-3 years of experience in a quality control laboratory in the pharmaceutical industry.
- Technical Skills: Proficiency in analytical techniques such as HPLC, GC, UV-Vis, and FTIR. Knowledge of GMP, GLP, and regulatory requirements.
- Soft Skills: Excellent attention to detail, strong problem-solving skills, effective communication, and ability to work independently and as part of a team.
Additional Requirements:
- Ability to work in a fast-paced environment and manage multiple tasks simultaneously.
- Strong organizational skills
- Strong organizational skills and ability to maintain accurate records.
- Willingness to work flexible hours, including weekends and holidays if necessary.