Overview:
Perform tests following the operating procedures of their area and the requirements of GMP regulations, in order to validate and transfer physical-chemical analytical methods, as well as release products under development.Perform operations related to the preparation of materials used in QC laboratories, as well as prepare solutions for specific use in the various tests in accordance with operating procedures and the requirements of GMP regulations, in order to perform the necessary analyses and tests.
Responsibilities:
- Physical-chemical control of the manufacturing process.o Prepare materials and set up equipment.o Prepare, control, and manage the reagents and solutions required for the tests to be performed.o Collaborate in the set-up and development of analytical methods and method transfers.o Perform maintenance on the equipment and materials required for these analyses in the laboratory.• Correct documentation of all process-related activities, always complying with operating procedures and GMP regulations.o Document all activities performed during the testing/inspection process.o Execute the required activities in the laboratory management computer system for the section.o Prepare, review, and propose modifications to SOPs, PTs, specifications, and Training Guides.o Conduct the training required to perform their duties and provide training to other analysts as appropriate.o Initiate investigation of discrepancies, incidents, or out-of-specification results, following the plant's established system.• Perform physical and chemical analyses of samples of products under development: o HPLC/UPLCo CE-SDS-R/NRo Osmolalityo pHo Visual appearance• Reception of used materials in the QC laboratories.• Preparation of solutions used for testing.
Qualifications:
- Education: Professional training in science or higher.• Languages: Fluent in Spanish and intermediate in English.• Experience (years/fields): 2+ years in the pharmaceutical/biotechnology industry or laboratory experience.• Specific knowledge: Physical-chemical techniques: HPLC/UPLC, CE, osmolality, pH, visual inspection, etc.• Travel: Not required.• Personal skills: Organized, teamwork, ability to organize tasks, and proactivity.