QUALITY CONTROL _ CHEMIST - HLL-IX

Job description

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: Masters 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. Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.