Manager Quality Control

Role & responsibilities

• Developing and Implementing QC Procedures:

  Creating and updating standard operating procedures (SOPs), specifications, and testing methods to ensure consistent quality.

• Analysis of Samples:

  Performing analytical testing on raw materials, in-process samples, intermediates, and finished products using techniques like HPLC, GC, and other relevant methods.

• Ensuring Compliance:

  Guaranteeing adherence to cGMP, GLP, and other regulatory guidelines, including documentation requirements.

• Investigating Deviations:

  Identifying and investigating out-of-specification results, incidents, and deviations, and initiating corrective and preventative actions (CAPA).

• Method Development and Validation:

  Developing and validating analytical methods for new or existing APIs and ensuring their suitability for quality control purposes.

• Equipment Qualification:

  Participating in the qualification of analytical instruments and equipment to ensure they are suitable for their intended use.

• Documentation:

  Maintaining accurate and up-to-date records of all quality control activities, including analysis reports, calibration records, and deviation investigations.

• Training:

  Providing training to other QC personnel on analytical techniques, procedures, and regulatory requirements.

• Collaboration:

  Working closely with other departments, such as production, R&D, and regulatory affairs, to ensure quality throughout the API lifecycle.

• Continuous Improvement:

  Participating in continuous improvement initiatives to enhance the efficiency and effectiveness of the QC processes.

Preferred candidate profile