Quality Control Analyst

Role & responsibilities

1. Analytical Testing using HPLC

• Operate and maintain HPLC systems for quantitative and qualitative analysis.
• Perform routine testing of raw materials, finished products, in-process samples, and stability samples.
• Analyse active pharmaceutical ingredients (API) for assay, impurities, degradation products, dissolution profiles, etc.

2. Method Execution

• Perform analysis using pharmacopeial (USP, BP, IP, Ph. Eur.) or validated in-house methods.
• Prepare mobile phases, standards, and sample solutions as per method protocols.
• Adhere to system suitability criteria before sample analysis.

3. Data Handling and Documentation

• Record and document chromatograms, peak integrations, system suitability, and raw data accurately.
• Prepare analytical reports, calculation sheets, and ensure entries in logbooks and LIMS (if applicable).
• Ensure compliance with

  ALCOA+

  principles of data integrity.

4. Instrument Maintenance and Calibration

• Perform routine instrument checks and minor maintenance (e.g., flushing, degassing).
• Document instrument usage and maintenance logs.
• Coordinate with engineering/QA for scheduled calibration and preventive maintenance.

5. Compliance and Good Laboratory Practices (GLP)

• Follow GMP and GLP guidelines in all laboratory operations.
• Ensure correct labelling, storage, and disposal of chemicals and reagents.
• Maintain personal protective equipment (PPE) usage and safety protocols in the laboratory.

6. OOS, OOT, and Deviation Handling

• Immediately report abnormal results (Out of Specification/Out of Trend) to supervisors.
• Assist in root cause analysis and CAPA implementation.
• Participate in re-analysis, investigation, and documentation of any laboratory incident.

7. Stability & Validation Support

• Perform stability study testing at predefined intervals.
• Assist in method validation/verification activities using HPLC.
• Document test results for inclusion in stability or validation reports.

8. Reagent and Column Management

• Label, prepare, and store reagents and mobile phases properly.
• Maintain column inventory, usage logs, and cleaning schedules.
• Ensure traceability and suitability of reference standards and working standards.

9. Regulatory and Audit Preparedness

• Ensure laboratory readiness for audits (USFDA, WHO, MHRA, etc.).
• Maintain proper archiving and traceability of HPLC test data.
• Present analytical data and records during internal and external inspections.

Preferred candidate profile

Educational Qualifications & Experience

• Qualification:

  B.Pharm / M.Pharm / M.Sc. in Analytical Chemistry, Pharmaceutical Chemistry, or equivalent.

• Experience:

  14 years of experience operating HPLC in a regulated pharmaceutical QC environment.

• Technical Knowledge:

  Proficiency in operating HPLC systems (Waters, Shimadzu, Agilent) and software (Empower, Lab solutions).