Key Responsibilities:
Sampling and Analysis:
- Perform sampling of raw materials, intermediates, and finished Active Pharmaceutical Ingredients (APIs) according to standard procedures.
- Conduct routine and non-routine chemical and physical tests to ensure quality standards are met.
- Analyze products using techniques such as High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), UV-Vis spectroscopy, FTIR, and other analytical instruments.
Documentation:
- Accurately document all analytical results and observations in laboratory notebooks or electronic systems.
- Prepare and review certificates of analysis (CoA) for finished products and intermediates.
- Ensure compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP) in all documentation.
Compliance and Standards:
- Adhere to established quality standards as per pharmacopeias (USP, BP, IP, EP, etc.) and regulatory guidelines.
- Ensure that all QC activities comply with regulatory and company standards, including FDA, ICH, and WHO requirements.
- Participate in internal and external audits and implement corrective actions where required.
Instrument Calibration and Maintenance:
- Perform regular calibration, qualification, and preventive maintenance of laboratory equipment.
- Troubleshoot and resolve instrument issues in collaboration with the maintenance or engineering team.
Stability Studies:
- Conduct stability studies for APIs to determine shelf life and storage conditions.
- Monitor and report stability data as per ICH guidelines.
Deviations and Investigations:
- Identify and report deviations or out-of-specification (OOS) results.
- Participate in root cause analysis and provide recommendations for corrective and preventive actions (CAPA).
Method Development and Validation:
- Assist in the development, optimization, and validation of analytical methods for new APIs.
- Support the transfer of validated methods to production and QC teams.
Training and Knowledge Sharing:
- Train junior staff on QC procedures, analytical techniques, and safety protocols.
- Stay updated on new analytical methods, regulatory requirements, and quality standards.
Qualifications and Skills:
- Education:
- Master's degree in Analytical Chemistry, or Organic Chemistry or B. Pharmacy
- Technical Skills:
- Proficiency in analytical techniques such as HPLC, GC, UV-Vis, FTIR, and titration.
- Familiarity with laboratory software such as Chromeleon, LabSolutions, or Empower.
- Understanding of GMP, GLP, and regulatory requirements.
- Soft Skills:
- Strong analytical and problem-solving abilities.
- Attention to detail and commitment to quality.
- Effective communication and documentation skills.
Work Environment:
- Laboratory-based role with exposure to chemicals and analytical equipment.
- May require flexible working hours to meet project deadlines or address critical issues.
Key Performance Indicators (KPIs):
- Accuracy and reliability of analytical results.
- Timely completion of testing and reporting.
- Compliance with GMP/GLP and audit readiness.
- Effective resolution of OOS and deviations.
