Officer / Sr. Officer - Quality Control

Alkem Labs; Daman; On-site; INR 400,000 - 700,000; Full time

Job summary

Alkem Labs is seeking a skilled analytical chemist with strong chromatography expertise and experience in FP and stability testing. The role involves data trend analysis, adherence to GLP, and maintaining compliance with safety guidelines.

You will operate Empower software, manage LIMS/ELIMS data records, and monitor stability data trends to support quality control and regulatory requirements.

Qualifications

• Good chromatography techniques including HPLC/GC.
• Experience with FP and Stability sample analyses (RS, Assay, Dissolution, Content uniformity, Blend Uniformity).
• Proficiency in Empower software for chromatographic processing.

Responsibilities

• Monitor and analyze test data trends to identify OOT, OOS and lab incidents.
• Ensure safety and regulatory guideline compliance and good bench practices.
• Prepare analysis data records accurately in LIMS/ELIMS.
• Perform Stability sample analysis and trend stability data.

Skills

Chromatography

Analytical methods

GLP compliance

Data trend analysis

Regulatory awareness

Tools

Empower software

LIMS/ELIMS

Job description

• Candidate should have good analytical techniques of chromatography (Operation of HPLC, GC etc.)
• Sample analysis of FP and Stability samples (e.g. RS, Assay, Dissolution, Content uniformity, Blend Uniformity)
• Candidate should have chromatographic processing skill on Empower software.
• Knowledge of LIMS/ELIMS.
• Expertise in good laboratory practices (GLP), and the operation and maintenance of laboratory equipment.
• Monitor and analyze test data trend identifying OOT, OOS and Lab incident.
• Ensure compliance with safety, regulatory guideline including good workbench practices.
• Preparation of analysis data record accurately in LIMS/ELIMS.
• Stability Sample analysis and trending of stability data