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 recent methods, equipment, and lab procedures.

📌 Officer - Quality Control (Vapi)
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📍 Vapi