• Manage a team of approximately 15 people in quality control and quality assurance.
• Make sure that the facility is compliant to all regulatory bodies including FDA and Mexican authorities.
• Establish and define roles responsibilities, policies and procedures concerning the acquisition, maintenance, dissemination and disposition of data within the quality control department
• Coordinate activities by scheduling work assignments setting priorities and directing the work of subordinate employees.
• Develop a set of internal processes and best practices that guarantee good, reliable data is created and maintained through its flow in the supply chain.
• Specifications and vendor qualifications as product specification sheets
• Convey information, ideas and quality policy to all levels within the organization.
• Motivate and inspire employees to follow GMP regulations (21 CFR 210/211)
• Organize and ensure that all validations, process or equipment, are completed on time and that standard manufacturing adheres to this.
• Oversee finished product microbiology program and environmental program, including investigations
• Maintain and drive all CAPA, deviations, nonconforming material and out of specification investigations
• To be the driver of all GMP compliance and FDA compliance at the facility.
• Attend conferences, training sessions and meet-greets with FDA.
• Make sure all employees are operating in a 21 CFR 210/211 compliant manner.
• Associate’s degree in Bachelor’s degree in Chemistry, Biochemistry, Biology or a related a scientific discipline.
• 5-10+ years of experience, preferably understanding of cGMP concepts.
• Strong English skills in writing and verbal communication.
• Minimum two years’ experience in calibration and validation, preferably in a GMP manufacturing or laboratory environment.
• Proficient in Microsoft Word and Excel programs.
• Good organizational skills.
• Ability to multi-task effectively in a technical environment.
|Área||Control de Calidad|
|Edad||32 - 55 años|
|Horario||Lunes a viernes|