HPLC Analyst - Pharma Laboratory

Vardan Environet; Gurugram District; Sur place; INR 350 000 - 550 000; Plein temps

Résumé du poste

Vardan Environet in Gurugram is seeking a hands-on HPLC Analyst to support pharmaceutical QC. You will perform HPLC assays, dissolution studies, and impurity checks on tablets, capsules, syrups, injections, and creams, while preparing mobile phases, buffers, and standard solutions.

The role requires precise method execution, calibration, SST, and adherence to GMP/GLP with ALCOA data integrity. You will document results, participate in method validation and transfer, and assist stability testing

Qualifications

• Strong understanding of HPLC principles and detectors.
• Experience with pharmaceutical dosage forms.
• Familiarity with IP, USP, BP pharmacopoeias.
• Knowledge of OOS handling and data integrity.

Responsabilités

• Perform HPLC testing for assay and dissolution studies.
• Handle sample prep for tablets, capsules, syrups, injections, creams.
• Execute methods per pharmacopoeias or in-house.
• Operate and maintain HPLC systems; perform SST and calibration.
• Maintain GMP/GLP documentation and ALCOA-compliant records.
• Support stability testing and QC release activities.

Connaissances

HPLC analysis

Pharma analysis

ALCOA data integrity

GMP/GLP awareness

IP/USP knowledge

Outils

Waters HPLC

Agilent HPLC

Shimadzu HPLC

Description du poste

Key Responsibilities HPLC Analysis

• Perform HPLC testing for:
• Assay (active ingredient content) o Dissolution studies (mainly for tablets/capsules) o Related substances / impurities o Content uniformity
• Prepare mobile phases, buffers, and standard/sample solutions.

2. Sample Handling

• Analyze samples from:
• Tablets, Capsules (hard/soft gelatin)
• Syrups and oral liquids, Injection, Cream, Ointments and RM
• Follow proper sample preparation techniques like:
• Crushing, dilution, filtration, sonication

3. Method Execution & Validation

• Execute analytical methods as per:
• Pharmacopoeia (IP, USP, BP) o In-house methods
• Participate in:
• Method validation o Method transfer o Verification activities

4. Instrument Handling

• Operate and maintain HPLC systems (e.g., Waters, Agilent, Shimadzu)
• Perform:
• Calibration
• System suitability testing (SST) o Routine maintenance and troubleshooting

5. Documentation & Compliance Maintain records as per Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP)

• Prepare:
• Analytical reports o Raw data records
• Logbooks
• Ensure data integrity (ALCOA principles)

6. Stability & Quality Control

• Perform stability sample testing
• Support QC release testing of finished products

Required Knowledge & Skills Technical Knowledge

• Strong understanding of:
• HPLC principles (chromatography, detectors, columns) o Pharmaceutical dosage forms (tablets, capsules, syrups) o Dissolution apparatus (USP I/II)
• Familiarity with:
• Pharmacopoeias (IP, USP, BP)
• OOS (Out of Specification) handling