executive

Cadila Pharmaceuticals Limited; Ankleshwar; On-site; INR 300,000 - 450,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Ankleshwar, Gujarat, is seeking a meticulous Analyst for analytical laboratory work, focusing on HPLC analysis, data integrity, and compliance with cGMP and CFR 21 Part 11.

You will handle instrument calibration, LIMS documentation, stability testing, and collaboration with QC teams to ensure accurate results and timely reporting.

Qualifications

• Bachelor's degree in Chemistry or related field required.
• Experience with HPLC analysis and chromatographic techniques preferred.
• Familiarity with cGMP and CFR 21 Part 11 compliance.

Responsibilities

• Perform HPLC analyses and record results in worksheets and LIMS.
• Ensure data integrity and compliance with cGMP and CFR 21 Part 11.
• Maintain instrument logs and calibration status.
• Prepare stability protocols/reports and coordinate with QC for method transfer.

Skills

HPLC analysis

Data integrity

Documentation

Calibration

Education

Bachelor's degree in Chemistry or related field

Tools

LIMS

HPLC instrumentation

Job description

Job Description:

• To maintain and adherence of the GLP and safety procedures in laboratory.
• To perform the analysis as per work allocation and records the results in work sheet (Protocols) for raw material / packing materials/intermediates /APIs/ Stability and etc.. as per current specification and method of analysis.
• To work as Analyst and maintain the CFR 21 part -11 compliance by following laid down procedures.
• To perform all the HPLC related analysis and perform the online documentation for In-process, intermediate, finished products & returned goods / raw materials Hold time / Stability study / working standard analysis as per laid down specification & test procedures , SOPs, as per work allocation and report the analysis data in LIMS modules and report to Section – Head / Or QC head.
• To ensure that every specification and method of analysis used of right product/material code.
• To follow the instruction of Shift /Section In charge for analysis /planning.
• To report QI/NQI/OOS/OOT / Deviation/ discrepancy in laboratory analysis to QC- In charge and initiate of QI/NQI/OOS/OOT / Deviation.
• Responsible for performing calibration of laboratory instruments as per schedule and laid down SOPs with documentation and updation of instrument calibration status tag.
• To record and ensure all the entries, and results are in line with current specifications and STPs.
• To ensure the all column performance and column entry are maintain in column logbooks.
• To maintain instruments log books properly as per analysis.
• To acquire training from concerned person to update the cGMP system update technical knowledge.
• To maintain reference / working standard/impurity standard usage records.
• To maintain instrument history record.
• Joint analysis with A.R laboratory personnel during analytical method transfer on HPLC.
• Preparation of stability protocols and stability reports.
• To perform analysis of stability samples as per stability schedule
• Daily monitoring and recording of temperature and humidity of refrigerator / working standard chamber and laboratory area.
• Perform holding time study of intermediates and preparation of reports.
• Inform and Investigate OOS results in RM/Intermediates/APIs
• Ensure CFR 21 part -11 compliance and follow good chromatography practices during analysis, integration and reviewing of on line and off line chromatographic analysis to
• Maintain proper data integrity.
• To ensure no spillage of lab. Chemicals / solvents
• To prepare mobile phase/solution for analysis as per requirement to avoid wastage of lab chemicals and reagents/solvents.
• To coordinate with store department to prior information of urgent analysis of raw material.

Requirements: