Farmacéutico Responsable de Aseguramiento de Calidad (QA)

Placements24; Mexicali; Presencial; MXN 600.000 - 900.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive salary

Benefits package

Growth opportunities

Regulatory compliance culture

Descripción de la vacante

Placements24 seeks a Farmacéutico Responsable de Aseguramiento de Calidad (QA) for a state-of-the-art facility in Mexicali, Baja California. The role leads QMS implementation, quality control, and regulatory readiness, ensuring products meet global standards.

The ideal candidate holds a Pharm.D. with a valid Mexican license and 5+ years in QA/QC, with strong leadership, communication, and problem-solving skills.

Formación

• Doctorate in Pharmacy (Pharm.D.) or related science degree.
• Active Pharmacist license in Mexico.
• Minimum of 5 years in pharmaceutical QA or QC with cGMP knowledge.
• Experience managing QMS, audits and regulatory inspections.

Responsabilidades

• Develop, implement, and maintain the QMS in line with cGMP and regulations.
• Oversee QC/QA operations, including batch review, deviations, CAPA, and change control.
• Conduct internal audits; assist with external regulatory and client audits.
• Ensure manufacturing processes, facilities, and equipment meet quality standards.
• Manage qualification/validation of equipment, processes, and analytical methods.
• Review and approve product release documentation.
• Investigate quality issues and implement corrective actions.
• Train personnel on QA principles and procedures.
• Stay updated on cGMP and regulatory changes.
• Collaborate with R&D, production, and supply chain to embed quality.

Conocimientos

Leadership

Communication

Problem-solving

Educación

Doctorate in Pharmacy (Pharm.D.)

Descripción del empleo

About the Role

Our client is seeking an experienced and meticulous Farmacéutico Responsable de Aseguramiento de Calidad (QA) to join our state-of-the-art manufacturing facility in Mexicali, Baja California. This vital role ensures that all pharmaceutical products meet the highest standards of quality, safety, and efficacy, adhering strictly to national and international regulatory guidelines. The successful candidate will be responsible for developing, implementing, and maintaining robust quality systems throughout the entire product lifecycle, from raw material sourcing to finished product release. We are committed to excellence in pharmaceutical manufacturing and require a dedicated professional who can uphold our stringent quality benchmarks. This position is key to maintaining our reputation for producing safe and effective medications.

Key Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS) in accordance with cGMP and other relevant regulations.
• Oversee all aspects of quality control and quality assurance operations, including batch record review, deviation management, change control, and CAPA implementation.
• Conduct internal audits and participate in external regulatory inspections and client audits.
• Ensure that all manufacturing processes, facilities, and equipment comply with established quality standards.
• Manage the qualification and validation of equipment, processes, and analytical methods.
• Review and approve product release documentation.
• Investigate quality-related complaints and non-conformances, implementing corrective and preventive actions.
• Train personnel on quality assurance principles and procedures.
• Stay updated on current Good Manufacturing Practices (cGMP) and evolving regulatory requirements.
• Collaborate with R&D, production, and supply chain departments to ensure quality is integrated into all stages of product development and manufacturing.

Requirements

• Doctorate in Pharmacy (Pharm.D.) or a related science degree (e.g., Chemistry, Biology) from an accredited institution.
• Active and valid Pharmacist license in Mexico.
• Minimum of 5 years of experience in pharmaceutical Quality Assurance or Quality Control, with a strong understanding of cGMP.
• Proven experience in managing and implementing QMS, conducting audits, and handling regulatory inspections.
• In-depth knowledge of pharmaceutical manufacturing processes, analytical testing, and validation principles.
• Excellent leadership, communication, and problem-solving skills.
• Ability to work independently and as part of a team, managing multiple priorities effectively.
• Proficiency in relevant QA software and tools.
• Strong understanding of Mexican regulatory requirements (COFEPRIS) and international standards (e.g., FDA, EMA).
• High level of integrity and commitment to quality.

Benefits

• competitive salary
• a comprehensive benefits package
• opportunities for professional growth and development
• the chance to work in a modern manufacturing environment in Mexicali, Baja California
• stimulating and collaborative workplace culture focused on continuous improvement and regulatory compliance

Join our dedicated QA team and play a crucial role in ensuring the quality and safety of life-saving medications.