Descripción y detalle de las actividades
You will direct and execute analytical techniques for raw materials, bulk products and finished products. As well as supporting quality control, compounding and production operations while ensuring strict compliance with Good Laboratory Practices (GLP), ISO 22716 and FDA regulations (21 CFR 210 and 211). FDA regulatory compliance
- ** Analytical Testing**: Conduct and report results for physical and chemical analyses such as pH, viscosity, acidity index, particle size, melting point, color, odor, and appearance for raw materials, Finished Goods and Bulk.
- ** Active Ingredient Analysis**: Perform chemical and instrumental evaluations of active ingredients in Raw materials, Bulk and Finished Goods.
- **Sampling Management**: Organize, plan, and execute the raw material, Bulk, Finished goods sampling process, ensuring accuracy and traceability throughout the testing cycle.
- ** Equipment Calibration & Qualification**: Manage the calibration, qualification, and maintenance of all QC laboratory
- ** Laboratory Management**: Oversee QC laboratory operations, ensuring adherence to established protocols and regulatory standards. Ensure the laboratory operates efficiently and safely, meeting ISO 22716 and 21 CFR regulations.
- ** Managerial Duties**: Lead and mentor QC analysts, providing guidance in complex decision-making processes, and managing day-to-day operations. Ensure that all team members follow GMPs and SOPs effectively.
- ** Coordination with R&D**: Work closely with R&D to ensure raw material, Bulk and Finished goods standards are met
- ** Regulatory Compliance**: Ensure all activities within the laboratory comply with FDA regulations. Participate in internal audits.
- ** GMP Walkthroughs**: Conduct frequent Lab inspections to ensure compliance with Good Manufacturing Practices (GMPs) and FDA requirements.
- ** Decision-Making**: Make critical, data-backed decisions in collaboration with the QC team to ensure quality and safety standards are continuously met.
- ** Safety Compliance**: Ensure adherence to company safety policies
Experiência y requisitos
**Minimum Requirements**
- Bachelor's degree in Chemistry, Biochemistry, or a related field.
- Minimum of 5 years of experience working in a cosmetic laboratory environment.
- At least 5 years of experience in instrumental analysis, particularly related to active pharmaceutical ingredients.
- Proficient in Microsoft Office and other relevant software tools.
- Strong attention to detail, with excellent analytical and problem-solving skills.
- Advanced proficiency in spoken and written English (preferred).
**Functional Competencies**
- ** Team Leadership**: Ability to lead a team effectively and foster a collaborative work environment.
- ** Accountability**: Ensure quality, safety, and compliance are maintained at all times.
- ** Focus & Initiative**: Proactively address challenges and streamline lab operations for optimal efficiency.
- ** Organizational Skills**: Ability to manage multiple tasks, prioritize efficiently, and meet deadlines.
Beneficios
- Beneficios de acuerdo a la LFT
- Seguro de gastos médicos
- Transporte
- Utilidades garantizadas
- Servicios medicos en planta
- Comedor
**Número de vacantes** 1
**Área** Calidad
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Estudios** Carrera con título profesional
**Inglés **Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No