Descripción y detalle de las actividades
Oversee the daily functions of all quality laboratories. Review and approve documentation generated by those labs.
Interact daily with production management to ensure quality systems are being followed in the manufacturing areas.
Oversee validation, calibration, IQ/OQ/PQ, OOS/CAPA, NCMR, deviations, writing and updating SOPs for processes that fall under the jurisdiction of quality and review and sign-off on SOPs issued by functional areas throughout the facility for compliance with 21 CFR 211.
Supervise and coordinate all quality-related employees. Manage resources, processes, procedures, and employee behavior.
Manage OTC stability program.
Collaborate with engineering department and other functional areas in the review and issuance of SWI's (standard work instructions).
Ensure Annual Product Review (APR) for drug products is completed by the end of the first quarter of following year.
Conduct routine audits of manufacturing areas, laboratories, quality systems and generate reports with recommendations. Drive immediate resolution for non-compliance.
Co-host FDA and 3rd party audits.
Oversee and document training program for quality employees and in conjunction with HR track and monitor training of new hires by functional area supervisors in compliance with 21 CFR 211.
Recommend additional training, education to assure progressive departmental advances.
Provide decisive leadership, manage manpower requisitions, hire qualified personnel, and conducts employee reviews.
Manage the daily quality operations in the Tijuana plant.
Assure capable qualified processes for the manufacturing of the products and execute compliance with all applicable regulations for the products, including the US FDA 21 CFR 210, 211 and European/EU Regulations.
Act as the delegate Quality Systems Management Representative as required.
Ensure operational plans are aligned with business objectives
Apply expertise to achieve financial and operational objectives.
Execute compliance with 21 CFR 211 and ISO 22716
Experiencia y requisitos
Bachelor's Degree in a scientific discipline.
Minimum 5-7 years of experience in a US federally regulated cosmetic, food, drug, or medical equipment facility.
At least 10 years of related experience in a regulated industry.
Expertise in FDA 21 CFR 210, 211 highly desired.
Validation, deviation, OOS, CAPA knowledge and experience.
Strong interpersonal skills with a history of strong leadership and communication skills.
Multitasking and time management abilities are essential.
Excellent verbal and written communication.
Organizational, prioritization, multi-tasking, attention to detail, critical thinking, and problem-solving skills are essential in a fast-paced, deadline sensitive environment.
Motivated, self-starter, organized, and effective communicator.
Proven capabilities in applying drive and initiative into projects.
Fluency in Spanish and English, written and spoken.
Ability to apply multiple and complex functional principles and processes.
Ability to read, analyze and interpret common scientific and technical bulletins, financial reports, and legal documents.
Lead auditor for 21 CFR 210, 211 and ISO systems.
Six sigma Green Belt Certification (Desirable Six sigma Black Belt Certification).
Management skills including budget preparation are required
Beneficios
Beneficios de acuerdo a la LFT
Seguro de gastos médicos
Transporte
Utilidades garantizadas
Servicios medicos en planta
Comedor
