Quality Control Associate

2 weeks ago

Surat Gujarat India, Gujarat Concept Medical Full time

Job Purpose:

To perform raw material, in-process, and finished product analysis using validated analytical techniques, ensuring compliance with GMP/GLP guidelines and regulatory requirements.


Key Responsibilities:

  • Perform analysis of raw materials, in-process samples, and finished products as per approved specifications, test methods, and protocols.
  • Operate, calibrate, and maintain analytical instruments including HPLC, FTIR, and GC.
  • Troubleshoot analytical instruments, particularly HPLC systems, and ensure uninterrupted laboratory operations.
  • Ensure proper documentation and data integrity in compliance with GMP and GLP guidelines.
  • Maintain and update laboratory records, test reports, calibration records, logbooks, and analytical worksheets.
  • Utilize server-based chromatography software for data acquisition, processing, and reporting for HPLC and GC systems.
  • Ensure compliance with Good Documentation Practices (GDP) at all times.
  • Coordinate with QA for out-of-specification (OOS) investigations, deviations, and corrective actions when required.
  • Ensure proper handling, labeling, storage, and disposal of samples and chemicals.
  • Support internal and external audits by providing required documentation and technical explanations.


Technical Skills & Knowledge:

  • Strong operating knowledge of HPLC, FTIR, and GC instruments.
  • Hands-on experience in calibration, operation, and troubleshooting of HPLC systems.
  • Knowledge of SAP for material management, data entry, or quality-related transactions.
  • Proficiency in MS Office applications (Word, Excel, PowerPoint).
  • Experience working with server-based chromatography software for HPLC and GC.
  • Understanding of GMP, GLP, GDP, and regulatory compliance requirements.


Educational Qualification:

  • B.Sc / M.Sc in Chemistry / Analytical Chemistry / Pharmaceutical Sciences or equivalent.


Experience:

  • 1–4 years of relevant experience in a QC laboratory within pharmaceutical / medical device / chemical manufacturing industries.

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