Quality Control Analyst

2 weeks ago

Nelamangala, Karnataka, India Biopharm Group Full time

Job Title: QC Analyst – HPLC Specialist

Location: Dabaspet , Bangalore – , India

Department: Quality Control

Industry: Pharmaceuticals (Formulations)

Experience: 2–5 years

Employment Type: Full-time

Company Overview:

We are a reputed pharmaceutical formulation company based out of Bangalore committed to delivering high-quality products to domestic  and export markets. We are currently seeking a skilled and detail-oriented QC Analyst with hands-on experience in HPLC to join our Quality Control team.

Position Summary:

The QC Analyst will be responsible for conducting analytical testing of raw materials, in-process samples, and finished products with a primary focus on HPLC. The ideal candidate should be well-versed in regulatory standards and capable of working in a fast-paced, cGMP-compliant laboratory environment.

Key Responsibilities:

  • Perform routine and non-routine analysis using HPLC for assay, dissolution, related substances, and stability studies
  • Preparation, review, and maintenance of test data, analytical records, and reports in compliance with GMP and GLP
  • Calibrate, operate, and troubleshoot HPLC and other analytical instruments (e.g., UV, FTIR, pH meter)
  • Conduct testing of raw materials, intermediates, and finished formulations as per pharmacopeial and internal specifications
  • Assist in method validation and transfer activities
  • Investigate and document OOS/OOT results and deviations
  • Ensure compliance with quality standards, SOPs, and regulatory requirements
  • Maintain proper documentation and data integrity in line with audit expectations

Qualifications and Skills:

  • B.Pharm / M.Pharm / M.Sc (Analytical Chemistry / Pharmaceutical Chemistry preferred)
  • 2–5 years of experience in a pharmaceutical QC lab
  • Strong hands-on experience in HPLC method execution and troubleshooting
  • Familiarity with regulatory guidelines (e.g., ICH, cGMP, WHO, USFDA)
  • Working knowledge of LabSolutions/Chromeleon / Empower or similar HPLC software
  • Good documentation skills and attention to detail
  • Ability to work independently as well as part of a team

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