Senior Chemical Quality Specialist

10 hours ago

Pithampur, Madhya Pradesh, India beBeeChemicalQuality Full time ₹ 11,27,643 - ₹ 22,08,500

Job Title: Senior Chemical Quality Specialist

The role of a Senior Chemical Quality Specialist involves ensuring the quality and purity of raw materials, packaging materials, intermediates, and finished products.

Key Responsibilities:
  • Sampling and Testing: Perform sampling of raw materials, packaging materials, intermediates, and finished products in accordance with Standard Operating Procedures (SOPs).
  • Analytical Techniques: Conduct chemical, physical, and instrumental analysis using techniques such as UV, IR, KF, etc., as per pharmacopeia methods or validated in-house methods.
  • Environmental Monitoring: Conduct water stability and environmental monitoring sample analysis.
  • Compliance: Maintain Good Laboratory Practices (GLP) and ensure all activities comply with Current Good Manufacturing Practice (cGMP) guidelines.
  • Documentation: Prepare, review, and maintain test records, logbooks, Certificates of Analysis (COAs), and stability data accurately.
  • Regulatory Compliance: Ensure proper documentation as per Accountability, Legal Defensibility, Completeness, Accuracy, Legibility, Durability (ALCOA) principles and execute pharmacopeia and non-pharmacopeia test procedures.
  • Maintenance and Calibration: Assist in method validation, instrument calibration, and verification activities.
  • Cross-Functional Support: Support analytical method transfer between sites when required and ensure materials and products meet specifications before release.
  • Investigations: Perform Out of Specification (OOS), Out of Trend, and deviation investigations with QA.
  • Laboratory Operations: Support in stability studies, product complaints, and market recalls from QC perspective, operate, calibrate, and maintain analytical instruments, including UV-Vis and KF, and ensure proper preventive maintenance and qualification of instruments.
  • Audit Support: Support internal, external, and regulatory audits, including FDA and WHO.
  • Data Integrity: Ensure laboratory compliance with data integrity requirements and follow laboratory safety protocols and handle hazardous chemicals with proper Personal Protective Equipment (PPE).
  • Continuous Improvement: Maintain cleanliness and orderliness in laboratory premises and participate in training programs to update knowledge of pharmacopeias and regulatory guidelines.
  • Process Optimization: Contribute to process improvements and lab efficiency initiatives.

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