Officer, Quality Control Testing

RXinsider LTD.; Dahej; On-site; INR 450,000 - 700,000; Full time

Job summary

RXinsider LTD. is seeking an Officer – Quality Control to execute routine QC analyses, support raw materials, in-process and finished product testing, and ensure cGMP/GLP compliance. The role emphasizes data integrity, SOP adherence, and ongoing training within the QC team.

The ideal candidate will have 1–5 years of QC experience in an API manufacturing setting and a relevant degree (M.Sc/M.Pharm/B.Pharm). Knowledge of LIMS and instrument maintenance will be beneficial.

Qualifications

• 1-5 years hands-on QC experience in API manufacturing
• M.SC / M.Pharm / B.Pharm in Chemistry or related field preferred
• Experience with QC instrument calibration/maintenance is desirable

Responsibilities

• Perform routine QC analyses and support timely release of materials
• Maintain instrument calibration and compliance with cGMP/GLP
• Assist in deviation/OOS investigations and CAPA implementation
• Ensure data integrity and SOP adherence
• Enter data in LIMS and maintain sample status
• Support stability studies and related documentation

Skills

QC operations

Analytical testing

Documentation

cGMP compliance

Education

M.SC / M.Pharm / B.Pharm – Chemistry or related discipline

Tools

LIMS

SOPs

Job description

Officer – Quality Control is responsible for executing and supporting routine QC laboratory activities, including analysis, documentation, and compliance with cGMP and GLP requirements. The role involves handling raw material, in-process, and finished product testing, supporting stability studies, maintaining instrument compliance, and assisting in deviation/OOS investigations. The position also supports data integrity, SOP adherence, and continuous improvement initiatives within the QC function.

Essential Functions – Officer, Quality Control

• Execute routine preventive maintenance, calibration, and verification activities of QC instruments as per approved SOPs.
• Perform analysis and support timely release of raw materials, intermediates, and packing materials as per approved specifications.
• Ensure day-to-day compliance with GLP, safety practices, and laboratory housekeeping requirements.
• Execute stability sample charging, withdrawal, testing, and documentation as per approved stability protocols.
• Support investigation of deviations, OOS, OOAL, and laboratory incidents; assist in implementation of CAPA.
• Prepare, revise, and follow QC-related SOPs, test methods, and specifications; ensure compliance in routine work.
• Perform audit trail checks and ensure adherence to data integrity requirements for computerized systems.
• Enter, verify, and maintain accurate analytical data and sample status in LIMS.
• Participate in training programs and support knowledge sharing within the QC team.
• Maintain analytical columns, reference standards, and laboratory consumables as per SOPs.

Qualifications

Education

• M.Sc / M.Pharm / B.Pharm – Chemistry or related discipline preferred.

Experience

• 1-5 years of hands‑on experience in QC operations within an API manufacturing facility.