Officer - Quality Control

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.