Supervisor de Fabricacion

Job Description

Comply with GMP/GDP at all stages of manufacturing and aseptic filtration. Plan manufacturing and filtration processes according to the production schedule aligned with demand requirements by coordinating personnel activities, material resources, and process equipment. Review production orders and production procedures, ensuring master documents are accurate and up-to-date. Prepare and review procedures for various instruments, equipment, systems, and processes within the sterile plant manufacturing area. Identify discrepancies between SOPs and actual practices and take corrective action. Train operators and assistants to perform their tasks effectively and efficiently. Ensure the sterile plant is always in compliance with national and international GMP and ready for audits. Analyze, prepare, and review investigations into deviations, quality complaints, etc. Implement change control, conduct risk analyses, prepare exams, and qualify operators, etc. Support product process validation, cleaning validation, and the manufacture of test batches, pilot batches, and transfer batches. Verify line cleaning, sanitizing, and clearing procedures, as well as perform startups, process controls, and documentation closure. Ensure adequate inventory levels of various consumables used in manufacturing areas, including detergents, sanitizers, filters, hoses, sterile gloves, and others. Ensure accurate and timely recording of MOP, SAP, RAP, and other data. Report and generate maintenance orders for equipment or systems that exhibit failures or deterioration and follow up on the corresponding repairs.

Qualification and Experience

Bachelor's degree in Pharmaceutical Chemistry, Pharmaceutical Engineering, Pharmaceutical Medicine, Chemical Engineering, or related field

+ 5 years of experience in ISO Class A, Class B, and ISO aseptic environments. 2 years of experience in simulated filling, +2 years of experience in manufacturing sterile solutions, suspensions, and semi-solids, and in aseptic filtration. At least 2 years of experience in Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) in aseptic operations.

Competencies