Production Supervisor - Injectable Packaging, Optical Inspection

Requirements:

• Bachelor's degree in IQ, IBT, IBP, QFB, QI, (Graduated with professional license)
• 2 years of experience in the manufacturing of sterile medicines and/or biological products
• Experience in supervision of the optical inspection and packaging process for Injectables (indispensable)
• Availability to rotate 2 shifts.
• Training in Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Knowledge of Quality Management Systems (QMS)
• Basic concepts of microbiology

Main Responsibilities:

• Supervise the optical inspection and packaging process of injectable products.
• Ensure compliance and execution of the weekly and monthly manufacturing program.
• Verify that activities adhere to GMP, GDP, and regulatory and internal guidelines throughout the entire production process.
• Verify that manufacturing and packaging processes comply with parameters, process controls, and current qualification of areas and equipment.
• Report activity follow-up to the immediate supervisor in a timely and proper manner.
• Preparation and updating of the area's SOPs, as well as follow-up on the training and coaching of the personnel under their charge.

Activities:

• Request the weekly production program from Management and distribute daily activities to personnel.
• Request necessary consumables for the production areas.
• Supervise and ensure the recording of activities in master documentation (Manufacturing instructions, logs, and GDP formats).
• Provide support to operators in the operation of process equipment.
• Verify equipment adjustments and specifications of in-process and finished products.
• Notify damages or possible operational risks in equipment.
• Ensure the timely closing and delivery of manufacturing files to Quality Assurance.
• Daily report of activities, process times, absences, and medical leaves.
• Report critical or major deviations in production, manufacturing, or QMS documents.
• Prepare, verify validity, and update the area's SOPs.
• Train and coach technical and operational personnel according to the procedure matrix.

Key Competencies:

• Process Control and Execution
• Results Orientation / Achievement of Objectives
• Leadership and Process Supervision
• Conflict Management
• Tactical or Operational Decision Making
• Working under Pressure
• Responsibility
• Adherence to Standards
• Service Attitude

-Requirements-

Minimum education: Higher education - Bachelor's degree 2 years of experience Languages: English Age: between 25 and 45 years old

Keywords: residente, encargado, supervisor, subgerente, responsable, coordinador, gestor, capitan, production, produce, fabricacion, manufactoring, elaboracion, making, manufactura, produccion, ocular