Maharashtra FDA Approved QC - Chemist

Post

Experience

Willingness to work flexible hours or shift work if required.

Location

Educational Qualification

• Perform routine Quality Control testing on raw materials, in-process samples, and finished API products to ensure compliance with specifications.
• Utilize standard analytical techniques such as HPLC, GC, Spectroscopy, titration, IR, and dissolution testing.
• Conduct tests for purity, potency, identity, and impurities in accordance with official monographs (e.g., USP, EP) or internal specifications.
• Assist in the development, validation, and qualification of analytical methods, ensuring they are suitable for their intended purpose and meet regulatory standards.
• Participate in method transfer from development to manufacturing.
• Optimize existing methods to improve efficiency and accuracy.
• Maintain accurate, clear, and complete laboratory notebooks and test records following Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
• Prepare detailed test reports with data analysis and conclusions, highlighting any deviations or issues.
• Review and approve laboratory data, ensuring the correctness of the results and interpretation.
• Ensure compliance with SOPs (Standard Operating Procedures) and GMP (Good Manufacturing Practices) documentation
• Ensure all testing activities comply with FDA, EMA, ICH, USP, and other regulatory guidelines.
• Maintain awareness of industry trends, regulations, and changes in API quality control requirements.
• Support audits and inspections by regulatory bodies or internal teams to ensure adherence to compliance standards.
• Support stability studies for raw materials and API products by monitoring and testing products over time under various conditions.
• Analyse stability data to ensure product shelf life and quality.
• Prepare stability protocols and reports.
• Work closely with the Quality Assurance (QA) department to investigate deviations, out-of-specification (OOS) results, and corrective/preventive actions (CAPA).
• Assist in the investigation of non-conformities and participate in root cause analysis for issues related to product quality.
• Ensure proper maintenance, calibration, and performance verification of laboratory equipment.
• Monitor reagents and chemicals inventory to ensure availability for testing, and ensure proper storage and labelling.
• Adhere to safety protocols in the lab and ensure compliance with health and safety regulations.
• Participate in internal training on quality control procedures, new testing techniques, and regulatory updates.
• Assist in training junior QC chemists or new staff as required.
• Contribute to the ongoing improvement of Quality Control processes, laboratory procedures, and testing methods.