Purity Assurance Specialist

1 week ago

Dholka, Gujarat, India beBeeHplc Full time ₹ 9,00,000 - ₹ 12,00,000

Job Title: Purity Assurance Specialist

This is a challenging and rewarding role for an experienced HPLC Analyst seeking to leverage their skills in ensuring the quality and integrity of pharmaceutical, food, or chemical products.

The ideal candidate will possess strong analytical and problem-solving skills, with the ability to work effectively in a laboratory environment. They will be responsible for performing HPLC testing on raw materials, in-process samples, and finished products, as well as developing and validating new analytical methods.

Key Responsibilities:

  • Sample Analysis: Perform routine and non-routine analysis of samples using HPLC systems, including sample preparation, method execution, and data acquisition.
  • Method Development & Validation: Develop and validate new HPLC analytical methods or optimize existing ones for new products or processes, involving creating and executing protocols to demonstrate the method's accuracy, precision, and robustness.
  • Instrument Maintenance: Conduct routine maintenance, calibration, and troubleshooting of HPLC equipment and other lab instruments to ensure their proper functioning and data accuracy.
  • Documentation & Reporting: Meticulously document all analytical work, including raw data, results, and observations, in lab notebooks or LIMS (Laboratory Information Management System). Prepare and review reports, certificates of analysis (CoAs), and other quality documents.
  • Compliance & Audits: Ensure all work is performed in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and standard operating procedures (SOPs). Participate in internal and external audits to demonstrate compliance.
  • Data Integrity: Maintain the integrity of all data generated, reviewing and approving data from junior analysts and ensuring that all records are complete, accurate, and traceable.
  • Troubleshooting & Investigation: Investigate out-of-specification (OOS) or out-of-trend (OOT) results, identify the root cause, and implement corrective and preventive actions (CAPA).

Required Qualifications:

  • Education: A bachelor's or master's degree in Chemistry, Biochemistry, or a related scientific field.
  • Experience: 2-5 years of experience working with HPLC and other analytical techniques in a QC, R&D, or manufacturing environment, with experience in a cGMP-regulated industry highly preferred.

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