QA/QC Chemist (Organic Chemistry)

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 skills.

  lities

Preferred candidate profile