Quality Control Officer

Sterling Healthcare; Pune District, Talegaon; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sterling Healthcare Ltd. in Pune, Maharashtra, is seeking a QC Officer for HPLC analysis in its Formulation OSD plant. The role focuses on HPLC analysis of formulations and raw materials, ensuring GMP-compliant quality control and regulatory adherence.

The incumbent will operate HPLC systems, maintain records, and contribute to investigations of deviations while upholding ALCOA+ data integrity and collaboration with QA and Production.

Qualifications

• Bachelors or Masters in Chemistry or Pharmacy with relevant pharma QC exposure.
• Experience in QC testing and documentation in GMP/GLP environments preferred.
• Familiarity with IP, BP, USP, Ph. Eur. and in-house methods.

Responsibilities

• Perform HPLC analysis of finished products, in-process and raw materials.
• Prepare samples, standards, mobile phases, buffers for analysis.
• Operate, calibrate and maintain HPLC and QC equipment.
• Review chromatograms and system suitability parameters for compliance.
• Assist investigations of OOS, OOT and analytical deviations.
• Support method verification/validation and method transfer.

Skills

HPLC analysis

Chromatographic troubleshooting

Data integrity

Documentation

GMP/GLP

Education

B.Sc./M.Sc. Chemistry

B.Pharm/M.Pharm

Tools

HPLC instruments

UV-Vis spectrophotometer

Dissolution apparatus

Job description

Job Tittle QC Officer (HPLC Analysis)

Company: Sterling Healthcare Ltd.
Location: Pune, Maharashtra
Department: Quality Control (QC)
Plant: Formulation OSD (Oral Solid Dosage)
Position: QC Officer HPLC Analysis
Experience: 15 Years
Qualification: B.Sc./M.Sc. Chemistry, B.Pharm/M.Pharm or equivalent

Job Summary-

Sterling Healthcare Ltd. is looking for a qualified and motivated QC Officer for its Formulation (OSD) manufacturing plant in Pune. The candidate will be responsible for performing and documenting quality control analysis, with primary focus on HPLC analysis of pharmaceutical formulations and raw materials, in compliance with GMP and applicable regulatory requirements.

Key Responsibilities

• Perform HPLC analysis of finished products, in-process samples, stability samples, raw materials and packing materials as applicable.
  
• Carry out routine QC testing according to approved specifications, analytical methods, STPs and pharmacopoeial requirements.
  
• Prepare samples, standards, mobile phases, buffers and other solutions required for analysis.
  
• Operate, calibrate and maintain HPLC instruments and associated laboratory equipment.
  
• Review chromatograms, system suitability parameters and analytical results for compliance with specifications.
  
• Perform analysis as per IP, BP, USP, Ph. Eur. and approved in-house methods.
  
• Handle analytical instruments such as HPLC, UV-Visible spectrophotometer, dissolution apparatus, disintegration tester, pH meter and other QC equipment.
  
• Ensure proper documentation of analytical data, worksheets, logbooks and laboratory records in accordance with GMP/GLP and ALCOA+ principles.
  
• Assist in investigation of OOS, OOT, deviations and analytical errors.
  
• Support method verification/validation, method transfer and analytical troubleshooting activities.
  
• Participate in stability study sample analysis and maintain stability-related records.
  
• Ensure proper preparation, labeling, storage and disposal of samples and laboratory solutions.
  
• Follow laboratory safety procedures and maintain cleanliness and good housekeeping in the QC laboratory.
  
• Coordinate with Production, QA and other departments for timely completion of testing and release activities.
  
• Ensure compliance with company SOPs, data integrity requirements and applicable regulatory guidelines.
  

Required Technical Skills

• Good practical knowledge of HPLC analysis and chromatographic troubleshooting.
  
• Knowledge of HPLC parameters such as flow rate, wavelength, injection volume, column selection, mobile phase and system suitability.
  
• Understanding of assay, related substances/impurities and dissolution analysis.
  
• Basic knowledge of analytical method validation and verification.
  
• Knowledge of pharmacopoeial methods and pharmaceutical QC practices.
  
• Familiarity with GMP, GLP, SOPs, OOS/OOT and data integrity requirements.
  
• Good documentation and analytical reporting skills.
  
• Knowledge of handling computerized HPLC systems/CDS will be an advantage.