Analytical Development Specialist

6 days ago


Vadodara, Gujarat, India SUN PHARMA Full time
Job DescriptionJob Title: Senior Executive

Job Summary:

SUN PHARMA seeks a highly skilled Senior Executive to lead our analytical method development team. The ideal candidate will have expertise in developing and validating analytical methods for API/NCE samples.

Key Responsibilities:

  1. Develop and validate analytical methods for API/NCE samples using gas chromatography, liquid chromatography, and chemical analysis.
  2. Perform method validation for API/NCE purity, impurity, and excipients methods.
  3. Troubleshoot analytical issues for various products.
  4. Maintain, calibrate, and troubleshoot HPLC and GC instruments.
  5. Prepare SOPs for related instruments and systems.
  6. Transfer and demonstrate methods at other locations as required.
  7. Document results using ATP, development reports, validation protocols, and validation reports.
  8. Ensure compliance with cGMP/OECD GLP and ICH guidelines.
  9. Develop basic knowledge of handling instruments like UV-visible spectrophotometers, HPLC, UPLC, Karl-Fischer titration, differential scanning calorimetry, USP dissolution apparatus, and other minor equipment.

Requirements:

Candidates should have a strong background in analytical chemistry and method development. Basic knowledge of ICH guidelines and cGMP/OECD GLP is required. Proficiency in handling various analytical instruments is essential.



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