Team Member - Quality Control ( Analytical Method Validations/Transfers)

Job Purpose

• TM QC (Method Validation & Transfer) - API & Finished product
• Should able handle troubleshooting of analytical methods during validation, along with preparation of protocols and reports, and provide guidance to the other olleagues.
• Should experience in preparation of validation protocols and reports.

Team member for analytical method validations/transfers to handle product.

Should have knowledge and hands-on experience in Analytical Method Transfer (AMT), Method Validation, and Method Verification.

Should have sound knowledge and experience in investigations and report preparation for Deviations and OOS.

Should have knowledge and hands-on experience in protocol and report preparation in DocHUB for AMT, AMV, and Method Verification.

Should have real-time working knowledge of LIMS and EMPOWER applications, including chromatographic data processing.

Should have hands-on experience in handling HPLC, GC, and UPLC systems.

Should be able to independently plan and execute AMT, AMV, and Method Verification activities.

Should have hands-on experience in handling LC-MS.

Educational Qualification

• M.Sc. in Analytical Chemistry / Organic Chemistry / Pharmaceutical Chemistry / Chemistry or equivalent

Experience

• 10-12 years of relevant experience in Quality Control or Analytical R&D within the pharmaceutical industry
• Proven hands-on experience in:
  • Analytical Method Transfer (AMT)
  • Analytical Method Validation (AMV)
  • Method Verification
• Exposure to regulated environments (USFDA, EMA, or other global regulatory agencies) is preferred

Mandatory Technical Skills

• Hands-on experience with HPLC, UPLC, GC, and LC-MS
• Strong working knowledge of EMPOWER software for chromatographic data handling
• Practical experience with LIMS
• Hands-on expertise in DocHUB for protocol and report preparation
• Sound understanding of ICH guidelines, cGMP requirements, and investigation processes