1. Manage resources to ensure product quality in the physicochemical control laboratory.
- Ensure compliance with Good Laboratory Practices (GLP).
- Ensure compliance with Good Manufacturing Practices (GMP).
- Approve or reject raw materials and/or products at any stage according to their specifications.
- Ensure that all required analyses are performed according to the specifications described in the analytical method, based on internationally recognized pharmacopoeias, or, in their absence, on the manufacturer's methodology.
- Approve sampling instructions, specifications, analytical methods, and other quality control procedures.
- Ensure investigations are conducted for out-of-specification results.
- Approve and monitor the analyses performed in the physicochemical control laboratory.
- Verify the maintenance of facilities, systems, and equipment. 10.
Ensure that equipment maintenance, as well as the respective qualification and calibration of instruments, is carried out.
- Ensure that initial and ongoing training is provided to the personnel in charge to meet the laboratory's needs.
Qualification and Experience
Bachelor's degree in pharmaceutical sciences and/or chemical sciences.