Quality Control Associate

4 years

0 Lacs

Posted:2 days ago| Platform: Linkedin logo

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Work Mode

On-site

Job Type

Full Time

Job Description

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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