Supervisor de Fabricacion

Lupin; México; Presencial; MXN 420.000 - 720.000; Jornada completa

Descripción de la vacante

Lupin in Mexico seeks a seasoned sterile manufacturing specialist to oversee GMP/GDP compliance across all stages of production, including aseptic filtration. You will plan processes, coordinate teams and resources, review master documents, and train operators to maintain audit-ready sterile facilities.

You will also drive investigations into deviations, support validations, and ensure proper change control and documentation across MOP/SAP/RAP systems.

Formación

• 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 in simulated filling and manufacturing sterile solutions, suspensions, and semi-solids.
• At least 2 years in GMP and GDP in aseptic operations.

Responsabilidades

• Comply with GMP/GDP at all stages of manufacturing and aseptic filtration.
• Plan manufacturing and filtration processes according to the production schedule.
• Coordinate personnel, material resources, and process equipment.
• Review production orders and master documents to ensure accuracy.
• Prepare and review procedures for instruments, equipment, and systems in the sterile plant.
• Identify discrepancies between SOPs and actual practices and take corrective action.
• Train operators and assistants to perform tasks effectively and efficiently.
• Ensure sterile plant readiness for audits and regulatory inspections.
• Analyze investigations into deviations and quality complaints and support investigations.
• Implement change control, risk analyses, and qualification activities.
• Support product/process validation and the manufacture of test, pilot, and transfer batches.
• Verify line cleaning, sanitizing, startups, and documentation closure.
• Maintain inventory of consumables (detergents, sanitizers, filters, hoses, gloves).
• Record data accurately in MOP, SAP, RAP, and related systems.
• Report maintenance needs and coordinate repairs.

Conocimientos

GMP

GDP

Aseptic operations

Quality assurance

Educación

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

Descripción del empleo

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.