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QA/QC Chemist

2 weeks ago

Thāne, Maharashtra, India fe71a81d-2ce6-422c-9cc9-140736e6180f Full time ₹ 40,00,000 - ₹ 65,00,000 per year

Role & responsibi

Quality Control (QC) Responsibilities

  • Perform qualitative and quantitative analysis of organic compounds using:

  • HPLC, GC, FTIR, UV-Vis, NMR, Karl Fischer, Titration, etc.

  • Conduct raw material, in-process, and finished product testing.

  • Monitor reactions and processes using TLC, GC, or HPLC.
  • Perform purity, assay, impurity profiling, residual solvent analysis, and structure confirmation.
  • Maintain laboratory instruments and perform calibration, system suitability tests, and troubleshoot issues.
  • Review chromatograms, spectra, calculations, and ensure data integrity.
  • Prepare COA (Certificate of Analysis) and release documentation.

Quality Assurance (QA) Responsibilities

  • Prepare, review, and update SOPs, STPs, and analytical methods.
  • Ensure compliance with GMP/GLP, safety standards, and regulatory requirements.
  • Conduct internal audits, document control, deviation management, CAPA, and change control.
  • Approve raw materials, packaging materials, intermediates, and final products.
  • Verify batch manufacturing records (BMR) and batch packaging records (BPR).
  • Participate in method validation, equipment qualification, and stability studies.
  • Ensure data integrity (ALCOA+ principles) and adherence to quality systems.

Essential Skills & Competencies

  • Strong knowledge of organic chemistry, reaction mechanisms, and synthesis.
  • Experience with chromatographic and spectroscopic techniques (HPLC, GC, NMR, IR, MS).
  • Hands-on lab experience in QC analytical testing.
  • Understanding of regulatory frameworks: GMP, GLP, ICH guidelines.
  • Ability to prepare and review technical documents.
  • Strong problem-solving, attention to detail, and analytical thinking.
  • Good knowledge of stability studies, impurity analysis, and data interpretation.
  • Strong communication and teamwork

Preferred candidate profile