Senior Quality Control Chemist

0 - 5 years

2 - 6 Lacs

Posted:13 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

Key Responsibilities:

1. Routine Analysis & Testing:

  • Perform analysis of raw materials, in-process, finished products, and stability samples as per approved specifications and test procedures.
  • Conduct analysis using instruments such as

    HPLC, GC, UV-Vis Spectrophotometer, FTIR, Dissolution Tester, pH Meter, and KF Titrator

    .
  • Ensure analytical results are recorded accurately and reviewed as per GLP and cGMP standards.

2. Documentation & Record Keeping:

  • Prepare and review analytical reports, COAs, and test records.
  • Maintain logbooks, stability registers, and instrument usage records.
  • Ensure compliance with

    Good Documentation Practices (GDP)

    and

    data integrity

    requirements.

3. Instrument Calibration & Maintenance:

  • Perform daily instrument checks and ensure calibration of analytical instruments as per schedule.
  • Coordinate with maintenance and service teams for preventive maintenance and breakdown handling.

4. Method Validation & Transfer:

  • Assist in

    method validation, verification, and method transfer

    activities.
  • Support the preparation and review of validation protocols and reports.

5. Investigations & CAPA:

  • Participate in the investigation of

    OOS (Out of Specification)

    ,

    OOT (Out of Trend)

    results, deviations, and incidents.
  • Support implementation and effectiveness monitoring of

    Corrective and Preventive Actions (CAPA)

    .

6. Audit & Compliance:

  • Support internal, external, and regulatory audits (e.g., WHO, FDA, MHRA, ISO, etc.).
  • Ensure readiness of QC documents and laboratory compliance during audits.

7. Training & Supervision:

  • Guide and train junior chemists/analysts in analytical techniques and documentation.
  • Monitor adherence to safety procedures and laboratory discipline.

Qualifications & Experience:

  • Education:

    B.Sc. / M.Sc. in Chemistry / Analytical Chemistry / Pharmaceutical Chemistry.
  • Experience:

    3 to 7 years in Quality Control in a

    pharma formulation manufacturing unit

    .

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