Method Optimization Analyst

2 weeks ago


Bengaluru, Karnataka, India beBeeAnalytical Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Analytical Method Optimization Specialist

The Job Summary entails the execution of analytical method development, validation, and verification activities. This includes optimization and transfer methods related to Compendia, In-house developed methods, Site transfer methods, Regulatory queries, Method Life Cycle Management (MLCM) studies, Supplier Driven Changes (SDC), and other procedural updates.

Key Responsibilities:
  • Develop and optimize analytical methods in compliance with regulatory procedures.
  • Validate and verify In-house methods, Compendia, SDC, MLCM, and Cleaning Analytical methods according to regulatory guidelines.
  • Prepare protocols and reports for method verification and method transfer activities.
  • Execute method transfer analysis and reporting tasks.
  • Maintain regulatory compliance and safety requirements within the Quality Control Laboratory environment.
  • Collaborate as a team member to achieve all outcomes in a safe and efficient manner.

This position requires a strong understanding of analytical methods, regulatory procedures, and laboratory operations. The ideal candidate will possess excellent communication and problem-solving skills, as well as the ability to work effectively in a team environment.

Required Skills and Qualifications:
  • Educational Background: Minimum Master's degree or equivalent qualification.
  • Knowledge, Skills, and Abilities:
    • Proficiency in Microsoft Office applications.
    • Knowledge in analytical method development and optimization activities.
    • Ability to perform multi-parameter analysis on HPLC instruments.
  • Experience:
    • Minimum 3-6 years of experience in GMP regulated Pharmaceutical Industry environments.

A dynamic work environment with opportunities for professional growth and development is offered by this company.



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