Quality Control Analyst

Job Title:

Experience:

The Quality Control Analyst is responsible for performing routine and non-routine analytical testing to ensure the quality, safety, and compliance of raw materials, in-process samples, finished products, and stability samples. The role requires strong hands-on experience with HPLC and GC in a regulated laboratory environment.

Key Responsibilities:

• Perform analytical testing using

  HPLC and Gas Chromatography (GC)

  according to approved specifications and methods
• Conduct analysis of

  raw materials, in-process samples, finished products, and stability samples

• Prepare and review

  analytical documentation

  , including test reports, worksheets, and logbooks
• Ensure compliance with

  GMP, GLP, and SOPs

• Perform

  method verification/validation

  and support method transfer activities
• Troubleshoot analytical issues related to instruments or methods
  
• Maintain and calibrate laboratory instruments, including HPLC and GC systems
  
• Participate in

  OOS, OOT, deviations, and CAPA investigations

• Support audits and regulatory inspections
  
• Ensure data integrity and proper documentation practices
  
• Maintain a clean, safe, and compliant laboratory environment
  

Required Qualifications & Skills:

• Masters Degree in

  Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field

• 35 years of hands-on QC laboratory experience

• Strong practical knowledge of

  HPLC and GC

• Experience working in

  pharmaceutical, API Bulk Drug

• Familiarity with

  ICH, FDA, and regulatory guidelines

• Good understanding of

  data integrity and GMP documentation

• Strong analytical, problem-solving, and communication skills
  
• Ability to work independently and as part of a team
  

Preferred Skills:

• Experience with

  empower or similar chromatography software

• Exposure to

  stability studies

• Knowledge of additional techniques (UV, IR, Karl Fischer, Dissolution) is an advantage

  Role & responsibilities

Preferred candidate profile