Research Associate - II

Cadila Pharmaceuticals Limited; Dholka; On-site; INR 600,000 - 900,000; Full time

Job summary

Cadila Pharmaceuticals Limited is seeking a qualified analyst to oversee analytical method development, validation, and method transfer activities. The role involves reviewing data, ensuring GLP/GDP compliance, and maintaining instrument calibration and related records.

The candidate will engage with regulatory queries, prepare SOPs, and coordinate with the plant site during method transfer activities to ensure smooth regulatory-adherence and data integrity across analytical operations.

Qualifications

• Experience in analytical method development and validation.
• Experience with method transfer and regulatory requirements.
• Knowledge of GLP/GDP regulations.

Responsibilities

• Review analytical method validation and method transfer protocol and report as per current regulatory requirements.
• Review regulatory queries from different regulatory agencies.
• Prepare and review standard operating procedures.
• Maintain HPLC calibration reports.
• Troubleshoot during day-to-day analysis with proper instrument care.
• Take care of Analytical HPLC spare parts.
• Maintain records for all analytical reports by entering data and timely release to concerned dept.
• Coordinate with Plant site during method transfer activity.

Skills

Analytical thinking

Detail orientation

Regulatory compliance

Tools

HPLC

Job description

Job Description

Principal task

• 1) Monitoring Analytical method development, Validation study and method transfer activities.
• 2) Review the analytical method development data, validation study data and method transferprotocol and reports.
• 3) Preparations of justifications
• 4) To maintain and observed GLP/GDP in working environment.
• 5) Investigation Study as per requirement.

Responsibilities

• 1) Review of analytical method validation and method transfer protocol and report as per the currentregulatory requirement.
• 2) Review Regulatory Queries of product receiving form different regulatory agencies.
• 3) Preparation and review of standard operating procedure.
• 4) Maintaining HPLC calibration report.
• 5) Trouble shooting during day-to-day analysis with proper instrument care.
• 6) Taking care of Analytical HPLC Spare.
• 7) Maintain records for all analytical reports by entering all the data and timely release the analyticalreports to concern dept.
• 8) Maintain Coordination with Plant site during Method transfer activity.

Requirements