Executive – Analyst (ARD) | USV | Mumbai

Job Description

Roles and Responsibilities:

Development/Routine/initial/stability analysis for development batches

• • Literature survey.
  • To perform stability/initial sample analysis and document results and present for checking and review.
  • To suggest if any changes are necessary in methods with supporting records.
  • To report correct results and minimize repeat analysis by eliminating personal errors.
  • To report immediately abnormalities and out-of-trend results.
  • Sample disposal after analysis.

Analysis for analytical method validations, method transfer and deficiencies from regulatory agencies, Standard generation

• • Analytical method development for all analytical methods e.g. Genotoxic impurities by LCMS, Nitrosamine analysis by LCMS, Related substances, etc.
  • Analytical method validation for all analytical methods e.g. Genotoxic impurities by LCMS, Nitrosamine analysis by LCMS, Related substances, etc.
  • Analytical method transfer for all analytical methods e.g. Genotoxic impurities by LCMS, Nitrosamine analysis by LCMS, Related substances, etc.
  • Protocols, report preparation for method validation and transfer.
  • Analysis for standard generation.
  • Analysis for deficiency response.

Reporting of analytical data and data management

• • To submit analytical raw data (Laboratory notebook, chromatograms, calculation sheet, etc.) for supervisors review, immediately after completion of reporting.
  • To avoid repeat analysis.
  • To report incident/investigation, out of specification (OOS), out of acceptance criteria (OAC) results, or deviation.

Resource management

• • To ensure the utilization of chemicals, solvents, and consumables in an economical manner.
  • To suggest measures if any to reduce the cost of operations.
  • HPLC column regeneration, as per requirement.

cGMP compliance, Training, and contribution toward department goals

1. • To perform calibration for instrument and updation of instrument status board.
   • To fill and report breakdowns related to instruments and maintain records of breakdown and service.
   • Adherence to cGMP requirements during the execution of all analytical activities.
   • To make entries in instrument log books.
   • To make entries in logbooks for innovator sample consumptions, in-house reference standards, working standards, and Pharmacopoeial standards.
   • SOP preparation, update, and adherence to SOP.
   • Attend all the scheduled trainings as per identified training needs and training calendar.
   • To adhere to Health, Safety, and Environment requirements.

Desired Candidate Profile:

• M.Pharma, Ph.D.
• 6-7 Years of Relevant Experience
• Job Location: Govandi