Officer - Quality Control

5 days ago

Vapi, Gujarat, India SDP HR Solution Full time ₹ 40,00,000 - ₹ 80,00,000 per year


Job Description:
 
Key Responsibilities

1. Sample Analysis and Testing:

  • Perform chemical and instrumental analysis of raw materials, intermediates, and finished API products according to approved specifications and Standard Testing Procedures (STPs).

  • Conduct testing using a range of laboratory instruments, including but not limited to:

    • High-Performance Liquid Chromatography (HPLC)

    • Gas Chromatography (GC)

    • Fourier-Transform Infrared (FT-IR) Spectroscopy

    • Ultraviolet-Visible (UV-Vis) Spectroscopy

    • Karl Fischer Titrator

    • Atomic Absorption (AA) Spectroscopy (if applicable)

  • Perform wet chemistry techniques such as titrations, pH measurements, and various chemical assays.

  • Analyze stability study samples as per protocol.

2. Documentation and Record Keeping:

  • Maintain accurate, detailed, and clear records of all tests performed, including raw data, calculations, and results, in laboratory notebooks and electronic systems.

  • Ensure all data and records are compliant with cGMP and data integrity principles.

  • Prepare Certificates of Analysis (CoAs) for finished products.

  • Review and approve analytical data generated by junior staff, if applicable.

  • Draft, review, and revise Standard Testing Procedures (STPs) and other QC-related documents.

3. Equipment Management and Calibration:

  • Perform routine calibration, qualification, and maintenance of laboratory instruments and equipment.

  • Troubleshoot equipment issues and coordinate with service engineers for repairs as needed.

  • Maintain a log of equipment usage, maintenance, and calibration records.

  • Ensure all equipment is in a validated state and ready for use.

4. Investigations and Quality Events:

  • Investigate Out of Specification (OOS), Out of Trend (OOT), and other atypical results.

  • Participate in root cause analysis (RCA) for quality events and assist in implementing Corrective and Preventive Actions (CAPA).

  • Collaborate with the Quality Assurance (QA) and Production departments to resolve quality issues and support deviation investigations.

5. Lab Compliance and Safety:

  • Adhere to all laboratory safety protocols, including the use of appropriate Personal Protective Equipment (PPE) and proper handling of hazardous chemicals.

  • Ensure the laboratory environment is clean, organized, and compliant with cGMP and good housekeeping practices.

  • Participate in internal and external audits of the QC lab.

  • Assist in the qualification and validation of new methods, equipment, and lab procedures.


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