Senior Pharmaceutical QA Specialist

2 days ago

Nelamangala Town, India beBeeAnalytical Full time ₹ 6,00,000 - ₹ 11,00,000
Job Title: QC Analyst

Key Responsibilities:

  • Execute routine and non-routine analysis using High Performance Liquid Chromatography (HPLC) for assay, dissolution, related substances, and stability studies.
  • Prepare, review, and maintain test data, analytical records, and reports in compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
  • Calibrate, operate, and troubleshoot HPLC and other analytical instruments such as Ultra Violet (UV), Fourier Transform InfraRed (FTIR), and pH meter.
  • Conduct testing of raw materials, intermediates, and finished formulations according to pharmacopeial and internal specifications.
  • Assist in method validation and transfer activities.
  • Investigate and document Out of Specification/Out of Trends (OOS/OOT) results and deviations.
  • Ensure compliance with quality standards, Standard Operating Procedures (SOPs), and regulatory requirements.
  • Maintain proper documentation and data integrity in line with audit expectations.
Qualifications and Skills:
  • Bachelor's or Master's degree in Pharmacy or Analytical Chemistry/Pharmaceutical Chemistry is preferred.
  • 2-5 years of experience in a pharmaceutical Quality Control laboratory is required.
  • Strong hands-on experience in HPLC method execution and troubleshooting is essential.
  • Familiarity with regulatory guidelines such as International Conference on Harmonisation (ICH), cGMP, World Health Organization (WHO), and United States Food and Drug Administration (USFDA) is necessary.
  • Working knowledge of LabSolutions/Chromeleon/Empower or similar HPLC software is required.
  • Good documentation skills and attention to detail are necessary.
  • Ability to work independently as well as part of a team is required.

As a Quality Control Analyst, you will be responsible for ensuring the quality of our products by performing various analytical tests and maintaining accurate records. You will also assist in the development and implementation of new methods and procedures to improve our product quality.

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